2008 Annual Report on Pesticide Residues. according to Article 32 of Regulation (EC) No 396/2005 1

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1 SCIENTIFIC REPORT OF EFSA 2008 Annual Report on Pesticide Residues according to Article 32 of Regulation (EC) No 396/ European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT The report presents the results of the monitoring of pesticide residues in food commodities sampled during the calendar year 2008 in the 27 EU Member States and two EFTA States (Norway and Iceland). The report also comprises the outcome of the consumer risk assessment of pesticide residues. Finally, the report provides some recommendations aiming to improve future monitoring programmes. In total, more than 70,000 samples of nearly 200 different types of food were analysed for pesticide residues by competent authorities. 96.5% of the samples comply with the legal maximum residue levels (MRLs) of pesticides. EFSA concluded that the long-term exposure of consumers did not raise health concerns. The short-term exposure assessment revealed that for 134 food samples analysed the acute reference dose (ARfD) might have been exceeded if the pertinent food was consumed in high amounts. KEY WORDS Pesticide residues, food control, monitoring, Maximum Residue Levels, consumer risk assessment, Regulation (EC) No 396/ On request of EFSA, Question No EFSA-Q , issued on 15 June Correspondence: praper.mrl@efsa.europa.eu 3 The report was prepared by the Pesticide Risk Assessment Peer Review (PRAPeR) Unit in collaboration with the Assessment Methodology Unit (AMU). Suggested citation: 2008 Annual Report on Pesticide Residues according to Article 32 of Regulation (EC) No 396/ [442 pp.]. doi: /j.efsa Available online: European Food Safety Authority, 2010

2 SUMMARY The report gives an overview of the control activities performed by EU Member States and EFSA countries in order to ensure compliance of food with the standards defined in European legislation on pesticide residues was an important year for the harmonisation of the Maximum Residue Levels (MRLs) for pesticides at European level. Whereas before 1 September 2008 a mixed system with harmonised Community MRLs for ca. 250 active substances and national MRLs for the remaining substances was in place, after this date harmonised MRLs became applicable for all active substances used in plant protection products that have the potential to enter the food chain. Because of these substantial changes in the European MRL legislation, the results of previous monitoring reports published by EFSA and the European Commission are not directly comparable with the results reported in this report. The comparability of the data among reporting countries and over time is hampered not only by the important change in the legal situation but also by other factors, such as the change in the number of the reporting countries over time, the difference in the design of the national monitoring plans and the data validation and recoding. Typically, in each European reporting country two monitoring programmes are in place: a national control/monitoring programme (designed by each country) and a coordinated European programme for which clear guidance is given on which specific control activities should be performed by the Member States. The EU coordinated programme aims to provide statistically representative data regarding pesticide residues in food available to European consumers. The lots sampled should be chosen without any particular suspicion towards a specific producer and/or consignment. Thus, the results obtained in the coordinated programme are considered as an indicator for the MRL compliance rate in food placed on the European common market and allow an estimation of the actual consumer exposure. Although the participation was not mandatory in 2008, all 27 Member States and the two EFTA states participated in the EU harmonised control programme. A total number of 11,610 samples of nine different commodities (oranges, mandarins, pears, potatoes, carrots, cucumbers, spinach, beans without pods, and rice) were taken in the 2008 EU coordinated pesticide monitoring programme. These samples should be analysed for 78 pesticides (including the relevant metabolites, as specified in the legal residue definition). 2.2% of the samples exceeded the MRL, while the percentage of samples with measurable residues above the quantification level, but at or below the MRL, was 35.7%. In 62.1% of the samples no residues were detected. The overall MRL exceedance rate was comparable with the previous year rate (2.3%). It is noted that the percentage of samples without measurable residues increased from 52.7% in 2007 to 62.1% in The highest percentage of samples exceeding the MRL was identified for spinach (6.2%) followed by oranges (3.0%), rice (2.4%), cucumbers (2.1%), mandarins (2.0%), carrots (1.8%), pears (1.6%), beans without pods (0.8%) and potatoes (0.5%). It should be noted that the presence of pesticides, even an exceedance of an MRL, does not imply that this is a food safety concern. To ascertain the latter exposure assessments are required. The official controls carried out at national level in the framework of the national monitoring programmes are complementary to the control performed in the context of the EU coordinated programme and are performed to ensure compliance with the provisions established in food legislation regarding the pesticide residues. Member States and EFTA countries are free to decide on the design of the national monitoring programmes for pesticide residues in food. 2

3 The total number of samples taken in the context of the national programmes in 2008 was 70, This includes 67,887 surveillance samples and 2,256 enforcement samples. Compared with the previous year, this is a decrease by 5.9 %. National programmes cover samples originating from national, Community and third country production. The majority of samples taken were produced in one of the European reporting countries (77%), while 20% of the samples were taken from imported consignments or lots. For 3 % of the samples the origin was not reported. Approximately 200 different unprocessed food commodities were analysed for pesticide residues by all reporting countries. In 2008 the number of pesticides sought by each country varied from 39 to 679. The total number of substances covered by all reporting countries was 862. In total, residues of 365 different pesticides were found in measurable quantities in fruit and vegetables, while in cereals residues of 76 different pesticides were observed. As in previous years, the number of different pesticide residues found in fruit and vegetables in 2008 was higher than the number of pesticides found in cereals, which also reflects the greater number of products used in the fruit and vegetables category. 96.5% of the surveillance samples analysed were below the legally permitted limits, while 3.5% of the samples exceeded the MRLs. The overall reported MRL exceedance rate (3.5%) is lower than in the previous year where 4.2% of the samples were found to exceed the MRLs. A higher incidence of MRL exceedances was also observed in samples imported from third countries (7.6%) than from EU (2.4%). A significantly higher MRL exceedance rate was observed for enforcement samples (10.3%) compared to surveillance samples (3.5%). The former are taken when there are suspicions about the safety of a product and as a follow-up of violations found previously. For baby food, the European legislation is more restrictive than for other food categories as no more than 0.01 mg/kg of any single pesticide residue is permitted in baby food samples. In 2008, a total of 2,062 surveillance samples of baby food were reported by 25 countries. Quantifiable residues above the reporting level were found in 76 samples, while the MRLs were exceeded only in 4 samples (0.2%). At EU level no specific MRLs for organic products are established, i.e. the MRLs established for conventionally produced products apply. In 2008, the results of a total of 3,131 samples of organic origin were reported by 22 countries. For organic fruit and vegetables, a lower rate of MRL exceedances (0.9%) in comparison to conventionally grown fruit and vegetables (3.7%) was found. It should be mentioned that EU legislation allows the use of certain active substances in organic food production. Considering the results of both the national and the EU coordinated programmes (including enforcement samples), the percentage of samples of fruits, vegetables and cereals with multiple residues (i.e. single samples which contain residues of more than one pesticide) has increased over the time, from 15% in 1997 to 26% in In 2008, residues of two or more pesticides were found in 27% of the analysed samples of fruits, vegetables and cereals. The highest number of different pesticides in a single sample was 26 in 2008 and was recorded for a table grape sample. Multiple 4 This figure also comprises the number of samples taken for the EU coordinated programme since these samples in many countries were analysed for a wider range of active substances than defined in the coordinated programme and are therefore belonging to both programmes, the national and the EU coordinated programme. 3

4 residues in one sample can result from the application of different types of pesticides (e.g. insecticides, fungicides and herbicides) to protect the crop against different pests, diseases or other threats having an impact on the quality or yield of crops, from mixing of lots with different treatments, contaminations, but also from practices which do not respect the principles of good plant protection practice. The results of the monitoring were used to perform exposure assessments. However, this exercise was impeded by the fact that aggregated results, rather than results at single chemical determination level, were provided to EFSA. This lack of information was bridged by introducing conservative assumptions in the exposure modelling which bias the results by overestimating the actual consumer exposure. In order to improve the accuracy of the actual consumer exposure calculations with 2009 monitoring data, EFSA has developed and tested a new pesticide monitoring reporting format. The long-term exposure assessment was based on the residue findings for the food commodities which are the major constituents of the human diet. The calculations demonstrated for all except one pesticide that even under conservative assumptions the chronic (long-term) exposure does not exceed the toxicologically acceptable limits. For diazinon a potential consumer health risk could not be excluded in the first tier risk assessment. However, after having performed a more refined calculation, taking into account that residues are lower in food commodities that are consumed after processing (i.e. apple juice), EFSA concluded that the long-term consumer exposure to diazinon residues is not likely to exceed the Acceptable Daily Intake (ADI). Thus, also for diazinon no longterm consumer risk is expected. It is noted that the use of diazinon is no longer permitted in the European Union. The assessment of the acute (short-term) consumer exposure was performed for the nine food commodities which were analysed under the EU coordinated monitoring programme. The assessment was based on worst-case scenarios: the consumption data for consumers who eat a large portion size of the food item under consideration were combined with the highest residue measured in the coordinated programme. In order to accommodate for a possible non-homogeneous distribution of residues in an analysed food lot a variability factor was introduced. Assuming a coincidence of these events (high food consumption, high residue concentration and inhomogeneous residue distribution in a lot), a potential consumer risk could not be excluded for 35 pesticide/commodity combinations. The highest potential exceedances of the toxicological reference value was indicated for dimethoate/omethoate on potatoes and spinach (10,763% and 2,938% of the ARfD, respectively), methiocarb on cucumbers (2,519%), dimethoate/omethoate on pears (1,730%) and mthomyl/thiodicarb on oranges (1,644%). However, the critical intake events identified in the acute risk assessment calculations were considered very unlikely, taking into account the frequency of critical residues and the frequency of extreme consumption events. For 11 of the pesticide/commodity combinations for which a critical intake situation could not be excluded, risk management actions have already been taken by withdrawing authorisations or by lowering the MRLs. 4

5 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 5 Legal basis... 7 Terms of reference Introduction Design and background on the monitoring programmes EU coordinated programme Food commodities analysed Pesticides analysed Number of samples National programmes Number of samples national programmes Pesticides analysed national programmes Food commodities analysed national programmes Baby food monitoring Organic food monitoring Processed-food monitoring Origin of samples Quality assurance Results of the EU-coordinated monitoring programme Overall results for MRL exceedances Results by country Results by food commodity Results by pesticide-commodity combination Results by pesticides Results of the national monitoring programmes Overall results for MRL exceedances MRL exceedance rate over the time Origin of samples exceeding the EC MRLs Results by food commodity Results by pesticide/crop combinations Results for organic samples Results for baby-food samples Results for processed products Results for samples with multiple residues Reasons for MRL exceedances Dietary exposure and dietary risk assessment Model assumptions for the short-term exposure assessment Residue levels Processing/peeling factors Acute Reference Dose values (ARfDs) Presentation of the results of the short-term consumer exposure Limitation and uncertainties affecting the short-term exposure assessment Results of the short-term risk assessment Pesticide/crop combination for which a theoretical short-term risk could not be excluded Azinphos-methyl

6 Carbaryl Benomyl/carbendazim Chlormequat Chlorpropham Chlorpyriphos Diazinon Dimethoate/omethoate Endosulfan Imazalil Lambda-Cyhalothrin Methamidophos Methiocarb Methomyl/thiodicarb Oxamyl Parathion Procymidone Tebuconazole Pesticide/crop combinations for which the short-term risk assessment was not conclusive Cypermethrin Dithiocarbamates Folpet/Captan Pesticide/crop combinations for which the short-term risk assessment could not be performed Model assumptions for long-term risk assessment Residue levels Processing/peeling factors Acceptable Daily Intake values (ADIs) Presentation of the results of the long-term consumer exposure Limitations and uncertainties affecting the chronic exposure assessment Results of the long-term risk assessment Pesticides for which a chronic risk could not be excluded Diazinon Pesticides for which the chronic risk assessment was not conclusive Dimethoate/omethoate Pesticides for which the chronic risk assessment could not be performed Dichlorvos Triazoles Recommendations Acknowledgments References Abbreviations and special terms used in the report Appendices Appendix I 163 Appendix II Appendix III. 241 Appendix IV 275 6

7 LEGAL BASIS According to the EU legislation in place in 2008, EU and EEA Member States 5 (Iceland and Norway) had to carry out national monitoring programmes on pesticide residues and report the results to the European Commission and EFSA. General legal provisions for food inspections and monitoring were established by Regulation (EC) No. 882/2004 (EC 2004) on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare. The legal basis for the preparation of this Annual Report on the pesticide residues is laid down in Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC (EEC 1976; EEC 1986a; EEC 1986b; EEC 1990). These directives required Member States to establish national control programmes and to carry out regular official controls on pesticide residues in food commodities to check compliance with the Maximum Residues Levels (MRLs) for pesticide residues. Commission Regulation (EC) No. 645/2000 (EC 2000) provides for detailed implementing rules for the monitoring provisions of Directives 86/362/EEC and 90/642/EEC (EEC1986a; EEC1990) on pesticide MRLs. On 1 September 2008, Regulation (EC) No. 396/ on maximum residue levels of pesticides in or on food and feed of plant and animal origin (EC 2005a) became fully applicable, and the provisions regarding the monitoring activities in the above-mentioned four directives were replaced by Chapter V of Regulation (EC) No. 396/2005. According to Article 31 of this regulation, Member States have to submit the results of official controls and other relevant information to the European Commission, to EFSA and to other Member States. With Article 32 the responsibility for preparing the Annual Report on pesticide residues was transferred from the European Commission to EFSA. This regulation also contains general provisions regarding the content of the Annual Report. In addition to the general provisions on national monitoring programmes as defined in Article 30 of the MRL Regulation, the Commission has recommended that EU Member States and EEA countries participate in a specific EU coordinated monitoring programme. The details of the coordinated monitoring programme for 2008 have been established in Commission Recommendation 2008/103/EC (EC 2008a). The results of the analysis of samples taken during the previous year under the national and coordinated Community monitoring programme had to be submitted to the European Commission by the end of August All 27 EU Member States and two EEA States submitted the results of the 2008 monitoring programme electronically to EFSA between 10 July and 30 October Liechtenstein, an EFTA State previously reporting its results on the monitoring of pesticide residues to the Commission, has been exempted from reporting obligations from 2007 due to a change in the EEA agreement concerning agricultural issues. 6 Regulation (EC) No. 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EECText with EEA relevance. Official Journal L 70, , p 1-16 (EC 2005a) 7

8 TERMS OF REFERENCE In accordance with Article 32 of Regulation (EC) No. 396/2005 (EC 2005a), EFSA shall submit the Annual Report on pesticide residues concerning the control activities carried out in 2008 to the Commission. The Annual Report shall at least include the following information: An analysis of the result of the controls on pesticide residues provided by EU Member States and EEA States; A statement of the possible reasons why the MRLs were exceeded, together with any appropriate observations regarding risk management options; An analysis of chronic and acute risks to the health of consumers from pesticide residues; An assessment of consumer exposure to pesticide residues based on the information provided under the first bullet point and any other relevant information available, including reports submitted under Directive 96/23/EC (EC 1996b). In addition, the report may include an opinion on the pesticides that should be included in future monitoring programmes. 8

9 1. Introduction The report presents the results of the monitoring of pesticide residues in food commodities sampled during the calendar year 2008 in the 27 EU Member States and the two EFTA States (Norway and Iceland ) who have signed the Agreement on the European Economic Area (EEA agreement). The objective of this report is to give an overview of the control activities performed by Member States and EFTA countries in order to ensure compliance of food with the standards defined by Directive 86/362/EEC, 90/642/EEC (applicable until end of August 2008) and Regulation (EC) No. 396/2005, to summarise the results provided by the reporting countries, to identify critical areas of concern regarding sample compliance with MRLs, to assess the actual consumer exposure to pesticide residues and to perform an analysis of the chronic and acute risks to consumer health. Furthermore, this report provides some recommendations for future monitoring plans and activities was an important year for the harmonisation of the pesticide MRL legislation at European level. Whereas before 1 September 2008 a mixed system with harmonised Community MRLs for about 250 active substances and national MRLs for the remaining substances was applicable, when Regulation (EC) No 396/2005 was introduced it harmonised MRLs for all active substances used in plant protection products that have the potential to enter the food chain. Due to the changed legal situation, the results of previous monitoring reports published by EFSA and the European Commission are not directly comparable with the results reported in this report. Therefore, the 2008 monitoring data should be interpreted at with care to understand if a possible change of the pesticide residue findings should be ascribed to the new harmonised EU legal limits or to other factors. The impact will be best evaluated by assessing future monitoring data, starting from the 2009 monitoring results. Finally, when comparing the data and results reported by the different countries and for different years, the reader should bear in mind that important changes in the legal framework have been introduced. The comparability is also hampered by other factors, such as scope of the national monitoring programmes, proficiencies of analytical laboratories providing results, the data validation and recoding 7. Chapter 2 of the report describes the design of the monitoring programmes in place in Europe. In particular, the difference between the EU coordinated programme and the national control plans is explained. The results of the EU coordinated monitoring programme, as established in Commission Recommendation 2008/103/EC, are reported in chapter 3 of this report. Key figures and results of the national control programmes are summarised in chapter 4. In this section the results of surveillance samples (non-targeted samples) and the results of the national enforcement sampling taken under the national control programmes are reported. In the last section of the report (chapter 5), EFSA assessed the dietary exposure of European consumers, based mainly on the results of the EU coordinated programme. 7 More detailed information about the results of control activities in the individual reporting countries is available from the respective national authorities. The list of web addresses where the results of monitoring plans have been published is reported in Appendix I. It should be noted that upon submission of the data, EFSA validated the data and recoded the names of the food and the pesticide names reported by the participating countries to make the comparable. If there were inconsistencies in data from different countries, they were asked for corrections. Therefore, small differences in the data published separately by the national authorities and the data reported in the present report may occur. 9

10 The reader not familiar with terms and concepts frequently used in the present report (e.g. MRL and sampling strategy) is invited to consult the background information section below. 10

11 BACKGRUND INFORMATION This section provides explanations on terms frequently used in the present report. Authorisation of pesticides/plant protection products The quality and yield of agricultural and horticultural crops is jeopardized by plant diseases and infestation by pests. In order to protect crops before and after harvest, pesticides 8 are used. Since the active substances used in pesticides can have harmful effects on human health, wildlife and the environment, a strict system of pesticide authorisation and control of use has been established at EU level. In the framework of the authorisation procedure, companies asking for the authorisation of products have to demonstrate that with regard to consumer safety the products do not pose a consumer health risk from pesticide residues on food. Pesticide residues Pesticide residues are the measurable amounts of the active substances used in plant protection products, their metabolites and/or breakdown or reaction products resulting from current or formerly used plant protection products that can be found on harvested crops or in food of animal origin. Pesticide use The nationally authorised or registered use of a pesticide reflects the safe use of a pesticide under actual agricultural conditions and implies the use of the minimum quantity of pesticides which allows the desired effect to be obtained (referred to as the Good Agricultural Practice - GAP). Authorisations are granted at national level, taking into account the local and environmental conditions and the occurrence of pests (and therefore the use of pesticides). MRLs are set for the most critical authorised GAPs, provided that a consumer health risk can be excluded for these uses. Residue definition Active substances applied on a crop are not stable, but the molecule applied undergoes to a certain extent a transformation induced by plant enzymes, light, humidity or other environmental factors. Thus, on the harvested food commodity, other chemical molecules than the active substances originally applied may be present. Since not all of these degradation products are harmless, they have to be taken into account in the consumer risk assessment. In certain cases, the parent compound (i.e. the substance originally applied on the crop) is not found at all in the harvested crops, but only a typical metabolite which is an indicator of the use of this parent compound. The concept of residue definition is used to define the active substance used in plant protection products and its metabolites, degradates, and other transformation products relevant for consumer exposure (i.e. residue definition for risk assessment) or to define marker substances allowing a conclusion on the use of the active substance (i.e. residue definition for MRL enforcement). For each pesticide used on food or feed commodities, the regulatory authorities need to choose which components of the terminal residue on the harvested crops are of relevance for setting and enforcing MRLs and for the dietary exposure. Therefore, for each pesticide, two residue definitions are set: Residue definition for MRL setting /MRL enforcement purposes focuses on those analytes which are indicators for the use of the pesticide and which can be analysed in routine monitoring, ideally by a multi-residue method. Residue definition for dietary risk assessment includes the parent compound and its metabolites, which are significant in term of relative toxicities and which contribute significantly to consumer exposure. 8 In the report the term pesticide is used as synonym of plant protection product. 11

12 MRL Maximum Residue Levels (MRLs) for pesticides are defined as the upper legal levels of a pesticide residue concentration (expressed in mg/kg) in or on food or feed which result from authorised agricultural practices. Food with residues of pesticides above the MRL cannot be traded. Hence, MRLs are not necessarily toxicological safety limits, but reflect the use of minimum quantities of pesticides to achieve effective plant protection, applied in such a manner that the amount of residue is the smallest practicable. Before an MRL is established, a risk assessment has to prove that the limit is safe for consumer health. In the past responsibility for risk assessment in the MRL setting procedure was shared between Member States and the European Commission. Since Regulation 396/2005 (EC 2005a) became fully applicable on 1 September 2008, EFSA has become the independent, responsible body for the risk assessment and evaluation of each intended new/revised MRL in the framework of the MRL setting procedures. In most cases the MRLs are well below the toxicologically acceptable residue levels. If a pesticide residue is found on a given crop at or below the MRL, then the crop can be considered safe for consumer health. On the other hand, if a residue exceeds the MRL, it is not necessarily true that the consumer is at risk. In the latter case, an assessment of the expected exposure and a comparison with the toxicological reference values is necessary to conclude whether the food poses a consumer health risk. MRLs are established for raw commodities of plant or animal origin placed on the market, i.e. fresh or frozen products without processing, in many cases including non-edible parts of the crop such as peel. The description of the commodities and the parts of the products to which the MRLs apply can be found in the Annexes of the basic MRL directives (EEC 1976; EEC 1990; EEC 1986a and EEC 1986b) and in Annex I to Regulation (EC) No. 396/2005 (EC 2005a). At EU level, harmonized MRLs for pesticide residues in food applicable for the reference period January to August 2008 have been established in four basic directives (Council Directive 76/895/EEC (EEC 1976), Council Directive 86/362/EEC (EEC 1986a), Council Directive 86/363/EEC (EEC 1986b) and Council Directive 90/642/EEC (EEC 1990)), which cover more than 250 pesticides. In addition, for pesticides not covered by the European legislation in the reference period until September 2008, Member States had the possibility to establish MRLs at national level. However, not all Member States had subsidiary national MRL provisions in place. Starting from September 2008, EU MRLs have been established by Annexes II and III of Regulation (EC) No. 396/2005 (EC 2005a). This Regulation provides for a harmonised system for the setting of the MRL, which apply to all food commodities available in all EU Member States. This Regulation covers about 500 pesticides. For pesticides not explicitly mentioned in Annexes II, III or IV of the Regulation, a default MRL of 0.01 mg/kg is applicable. MRLs are established at the limit of quantification (LOQ) if a pesticide is not authorised for use on a specific crop. For processed or composite food commodities, the MRLs established in the MRL legislation for raw commodities are applied by taking into account changes in the levels of pesticide residues caused by processing or mixing (processing factors). It should also be mentioned that no specific MRLs for organic products have been established at EU level. For these products the same MRLs as for conventional products apply, but additional production and labelling rules have to be respected (EC 1991b). For infant formulae, follow-on formulae and for processed cereal-based foods and baby foods for infants and young children, a default MRL of 0.01 mg/kg is applicable, unless a specific lower MRL has been set in Directives 91/321/EEC and 96/5/EC (ECC 1991, EC1996a). 12

13 MRL exceedance Since the MRLs are closely linked to the Good Agricultural Practices (GAP), MRLs may be exceeded in cases where the GAP was not respected, such as the use of unauthorised pesticides; the use of pesticides not authorised for a specific crop; the use of an authorised pesticide on a crop for which an authorisation was granted, but not in compliance with the authorised GAP (e.g. higher application rate or shorter pre-harvest intervals). For products originating from third countries, the lack of import tolerance at EU level may also be a reason for MRL exceedance. Before September 2008, the lack of harmonisation for certain active substances which were covered by national MRL provisions was also a reason for exceeding MRLs, although the food was lawfully produced in the Member State of origin. In exceptional cases, MRL exceedance was observed for other reasons, such as: spray drift from neighbouring treated fields; contamination of crops at storage or packaging level; unfavourable weather conditions associated with a reduced residue decline rate. Finally, MRLs might be exceeded because the legal limits (MRLs) were set at inappropriate levels. MRLs are derived from relatively small data sets generated in supervised field trials. On rare occasion applications at the critical GAP may also lead to values above the MRL. Careful analysis of the monitoring data should make it possible to decide if certain MRLs need to be revised. In the context of this report the term MRL exceedance refers to a situation where the legal limit is exceeded numerically, without considering measurement uncertainty. Thus, this term should not be understood as MRL non-compliance that will have legal repercussions. See also MRL compliance/non-compliance. MRL compliance/non-compliance If the residue level measured in a sample, taking into account the measurement uncertainty, exceeds the legal MRL, the sample is considered as non-compliant and the competent national authorities shall apply the sanctions applicable to the infringements. The sanctions must be effective, proportionate and dissuasive. A sample is compliant with the MRL if the measured value does not exceed the MRL. Threshold residue/threshold MRL Since the MRL is not the toxicological limits, for the purpose of the risk assessment EFSA introduced two new concepts: the threshold residue level and threshold MRL. A threshold residue level is the theoretical, calculated maximum residue in the edible part of the crop which would be acceptable from a consumer safety point of view. The threshold residue gives an intake corresponding to 100% of the ARfD and it is calculated on the basis of the consumer group with the highest consumption per unit body weight (i.e. the most critical consumer) identified among all the national consumer groups for which consumption data are available to EFSA. The threshold MRL is the residue concentration that refers to the whole commodity, e.g. the unpeeled orange, and which gives an intake corresponding to 100% of the ARfD. For crops that are consumed in peeled and/or processed form, a peeling factor and/or processing factor has to be applied to the threshold 13

14 residue to derive the threshold MRL. If the crop of concern can be consumed as a whole without any processing/peeling- the calculated threshold residue and threshold MRL have the same value. Dietary exposure assessment and risk assessment Dietary exposure assessment is the quantitative evaluation of the intake of pesticides via food. In the chronic and acute risk assessment, the estimated long-term and short-term dietary exposure, calculated per kg body weight, is compared with the relevant toxicological reference values, i.e. the acceptable daily intake (ADI) and the Acute Reference Dose (ARfD), respectively (see ADI and ARfD above). A consumer health risk is identified if the estimated dietary exposure to a pesticide, taking into account the scientific uncertainties, exceeds the ADI and/or the ARfD. Acceptable Daily Intake (ADI) The Acceptable Daily Intake (ADI) is the estimated amount of substance in food, expressed on a body weight basis, that can be ingested daily over a lifetime, without appreciable chronic, long-term risk to any consumer. The ADI is set on the basis of all known facts at the time of evaluation, taking into account sensitive groups within the population (e.g. children and the unborn). Acute Reference Dose (ARfD) The Acute Reference Dose (ARfD) is the estimated amount of substance in food, expressed on a body weight basis, that can be ingested over a short period of time, usually during one day, without appreciable risk to the consumer (Regulation (EC) No. 396/2005 (EC 2005a)). The ARfD is set on the basis of the data produced by appropriate studies and taking into account sensitive groups within the population (e.g. children and the unborn). Analytical methods The results of monitoring analysis are strongly influenced by the analytical methods used to analyse the samples. The analytical methods used in pesticide residue analysis have to fulfil certain criteria regarding specificity, sensitivity, precision accuracy, robustness and linearity which are defined in guidance documents ((EC 2007b), post-registration guidance document). Also the scope of the analytical methods (the list of pesticides included in the analytical methods) has an impact on the number of positive findings in samples analysed. If the analytical method applied is not capable of detecting a certain pesticide active substance applied to the crop or its toxicologically relevant metabolites or break-down products - the sample may be considered by mistake to be free of pesticide residues. Additionally, if the analytical method is not sensitive enough, the pesticide will not be detected in cases where the residue occurs at a low concentration. Therefore, the results reported by reporting countries have to be considered in the context of the analytical methods used. The analytical methods used today to detect and quantify pesticide residues in food commodities fall into two general types of method: multi-residue and single-residue methods. Multi-residue methods are able to analyse a high number of different pesticide residues in the same sample. However, certain pesticides and metabolites cannot be included in multi-residue methods because of their physicalchemical properties (e.g. acidic or polar chemicals). In these cases, single-residue methods have to be applied. Single-residue methods allow the identification and quantification of only one or a few pesticide residues in one sample. Since these two types of method require a comparable processing time per sample, multi-residue methods are usually preferred over single-residue methods, as they are generally more efficient in terms of cost/benefit ratio. Single-residue methods are therefore preferable for samples where previous experience shows that it is likely that residues of the pesticides in question will be found. European Reference Laboratory (EURL) The European Reference Laboratories (EURLs), in the past called Community Reference Laboratories - CRLs), are appointed by the European Commission, co-ordinate, train staff, develop methods of analysis and organise tests to evaluate the skills of the different national control 14

15 laboratories. The overall objective of the EURLs is to improve the quality, accuracy and comparability of the results from official control laboratories. Limit of Quantification (LOQ) The Limit of Quantification (LOQ) is the lowest validated residue concentration, which can be quantified and reported by routine monitoring with validated methods (EC 2009). In the context of this report, when samples are reported as having residues below the LOQ it can mean that no pesticide residues occurs or that very low concentration are present at a level that cannot be quantified with acceptable certainty. In the present report, the term Reporting Level (see Reporting Level below) is also used as a synonym of the LOQ 9. Reporting Level (RL) The Reporting Level is lowest level at which residues will be reported as absolute numbers. It may represent the practical LOQ, or it may be above that level to limit costs. For EU monitoring purposes, where samples for surveys are analysed over a 12-month period, the same reporting limit should be achievable throughout the whole year (EC 2009). Interval of confidence Several tables show information on frequency (percentage) of e.g. number of samples with residues above MRL. The precision of the value is dependent on the sample size. To express the uncertainty of the estimation, 95% confidence intervals were calculated using the Clopper Pearson approach with F distribution (Johnson 2005). The true proportion of samples is most likely equal to the calculated value with 95% confidence that lies between the upper and lower confidence limits (UCI and LCI). It is important to note that when no exceedance of the MRL was observed, there is still the statistical possibility that the MRL is exceeded by other samples of the same food commodity. The one-sided confidence interval for no observed exceedance describes this possibility. Sampling methodology To ensure that a sample taken is representative for a given food lot/consignment, the sampling has to be performed according to the sampling methodology for the official control of pesticide residues, as established by Commission Directive 2002/63/EC (EC 2002). For most plant products the minimum size of a laboratory sample is between one or two kilograms of the food item. Sampling strategy The sampling strategy is the approach used to select the units of the target population subject to control. Implementation of an efficient, targeted sampling strategy would result in a higher percentage of positive findings and non-compliant results. Thus, it is important to stress that, for a correct interpretation of the results obtained in control programmes, information about the sampling strategy applied is indispensable. In the report, the following terminology has been used to distinguish between more, or less, targeted sampling. Surveillance sampling: samples are collected without any particular suspicion towards a particular producer, consignment, etc. Surveillance samples could be targeted for specific food products and countries, but the selection of samples is randomised. The samples taken in the framework of the EC coordinated programme are considered to be surveillance samples. Enforcement sampling: samples are taken if there is suspicion about the safety of a product and/or as a follow-up of violations found previously. The selection of the samples is not randomised and therefore 9 In the EU MRL legislation, the term LOD (Limit of Determination) is used instead of the term of LOQ. However, EFSA prefers using the term LOQ in order to avoid possible confusion with the term LOD that is used to indicate the Limit of Detection. 15

16 cannot be considered representative of the food available on the European market. Follow-up or enforcement sampling is directed to a specific grower/producer or to a specific consignment. Thus, the key difference between surveillance and enforcement sampling is not so much targeting but randomisation of the selected samples. In Appendix I to the present report more details on the general sampling strategies applied at national level are reported. Quality assurance All laboratories performing analysis of pesticide residues in food should be accredited to certain standards (EC 2004). However, until 31 December 2009, these analyses could also be carried out by non-accredited laboratories, provided that the laboratories had initiated the accreditation procedures, and that quality control schemes were in place (EC 2005b). Commission Recommendation 2008/103/EC (EC 2008a) requires Member States to provide information about the details of accreditation of the laboratories which carry out the analysis for the monitoring programme, about the application of the EU Quality Control Procedures for Pesticide Residue Analysis (EC 2009) and about their participation in proficiency and ring tests. It also requires the reporting countries contributing to the monitoring to provide the accreditation certificates. Rapid Alert System for Food and Feed (RASFF) If in control activities pesticides are found at a concentration level of concern for consumer health, the Rapid Alert System for Food and Feed (RASFF) circulates the information among competent authorities and measures are taken to protect the consumer. Thus, RASFF is to ensure that urgent notifications are sent, received and responded to in the shortest time possible by all members of the RASFF (EU Member States, Commission, EFSA and Norway, Liechtenstein and Iceland). 16

17 2. Design and background on the monitoring programmes To fulfil the requirements of Regulation (EC) No. 882/2004 (EC 2004), EU Member States perform official controls to ensure the compliance of feed and food samples with regard to the pesticide MRL legislation. Typically, in each European reporting country, two monitoring programmes are in place: a national control/monitoring programme (designed by each country) and a coordinated European programme which gives clear guidance on which specific control activities should be performed by the Member States EU coordinated programme The EU coordinated programme aims to provide statistically representative data regarding pesticide residues in food available to European consumers (EC 2005a). The lots sampled should be chosen without any particular suspicion towards a specific producer and/or consignment. Thus, the results obtained in the coordinated programme are considered as an indicator for the MRL compliance rate in food placed on the European common market and they allow an estimation of the actual consumer exposure. The establishment of a coordinated community programme was initiated in Since then, the number of participating reporting countries has increased; in 1996, 15 EU Member States and one EFTA State (Norway) reported their monitoring results, whereas in 2008 the number of participating countries was 29: 27 EU Member States and two EFTA countries (Norway and Iceland) who have signed the Agreement on the European Economic Area (EEA agreement). Over time, the programme was also extended with regard to the number of samples, the food commodities and the active substances to be analysed each monitoring year. The coordinated monitoring programme is laid down in Commission Recommendation 2008/103/EC concerning a coordinated Community monitoring programme for 2008 (EC 2008a) Food commodities analysed The major components of the European diet are constituted by 20 to 30 food products. Monitoring the pesticide residues in these commodities should provide a representative basis for estimating the exposure to pesticide residues in food of European consumers. In view of the resources available at national level, participating countries focus on the sampling and analysis of eight to nine products each year, which are tested in a three-year cycle, covering in total the major food items. Food commodities to be analysed in 2008, 2009, and 2010 in the framework of the EU coordinated programme are shown in table

18 Table : Food commodities (plant origin) to be monitored in the calendar years 2008, 2009, and 2010 in the framework of the EU coordinated programme (EC 2008a; EC 2008b) Beans without pods (a) Aubergines Apples Carrots Bananas Head cabbage Cucumbers Cauliflower Leek Mandarins Grapes Lettuce Oranges Orange juice (b) Peaches (c) Pears Peas without pods (a) Rye or oats Potatoes Pepper (sweet) Swine meat Rice Wheat Strawberries Spinach (a) Tomatoes (a): Fresh or frozen (b): For orange juice, reporting countries should specify the source, e.g. concentrate or fresh fruit (c): Peaches including nectarines and similar hybrids Figure shows the proportion of the food commodities included in the EU coordinated residue monitoring programme for 2008 and the next two years, compared with the total food consumption of food items of plant origin. The food consumption data were retrieved from national food consumption surveys either for the whole population, adults, children or selected consumer groups (e.g. vegetarians) or other sources of information suitable to conclude on the food habits of the European population such as food balance sheets (e.g. WHO diets). The data regarding the national food consumption were submitted to EFSA in the framework of the development of the EFSA PRIMo (Pesticide Residue Intake Model) and the details of the diet in each Member State can be found in the EFSA report on temporary MRLs (EFSA 2007). It should be noted that not all participating countries had submitted food consumption data to EFSA at that time and therefore are not represented in the graph. 18

19 DK adult ES adult FI adult FR all IE adult IT adult LT adult NL all PL all PT all SE all P90 UK adult UK vegetarian WHO Europe WHO cluster B WHO cluster D WHO cluster E WHO cluster F DE child DK child ES child FR infant FR toddler IT kids NL child UK toddler UK infant 0% 20% 40% 60% 80% 100% EU coor.pgm EU coor.pgm EU coor.pgm Other plant origin Figure : Contribution of the commodities covered by the coordinated monitoring programmes to the total food intake (excluding products of animal origin and sugar beet). DK adult ES adult FI adult FR all IE adult IT adult LT adult NL all PL all PT all SE all P90 UK Adult UK vegetarian WHO Europe WHO Cluster B WHO cluster D WHO cluster E WHO Cluster F DE child DK child ES child FR infant FR toddler IT child NL child UK Toddler UK Infant 0% 10% 20% 30% 40% 50% 60% Oranges Mandarins Pears Potatoes Carrots Cucumbers Spinach Beans (without pods) Rice Figure : Contribution of the commodities covered by the coordinated monitoring programme 2008 to the total food intake (excluding products of animal origin and sugar beet). 19

20 Figure shows the individual contributions of the food items included in the 2008 programme for the same European diets. From the consumption figures available it is noted that the nine crops selected for the 2008 monitoring programme represented 15% to 50% of the total dietary daily intake of products of plant origin, whereas the total contribution of the crops to be monitored in 2008, 2009 and 2010 ranged from 39% to 95% of the diets. These data demonstrate that the food items selected are representative of the total food consumption of European consumers and can therefore be used for assessing dietary exposure to pesticide residues via food Pesticides analysed The list of the 78 pesticides (including the relevant metabolites as specified in the residue definition) which was recommended to be analysed in 2008 in the EU coordinated programme is reported in Table This list has been extended substantially since the start of the coordinated monitoring programme in 1996, as it has integrated the findings of national control programmes, RASFF notifications and toxicological profiles of pesticides. The number of pesticides included has increased from nine in 1996 to the 78 included in 2008 (Figure ). It should be noted that for 65 pesticides analysed in 2008, harmonised EU MRLs were already in place on 1 January For the remaining 13 active substances, national MRL provisions were applicable until the end of August From 1 September 2008, with the establishment of Annex II and III of Regulation 396/2005, fully harmonised EU MRLs apply to all pesticides. Number of pesticides Sampling year Figure : Number of pesticides (residue definitions) included in the EU coordinated monitoring programme

21 Table : List of pesticides (residue definition for monitoring) included in the 2008 EU coordinated monitoring programme. Pesticide Residue definition according to Regulation 396/2005 on EU-MRLs (a) EU MRL in place on 01/01/2008? (y/n) Acephate y Acetamiprid Aldicarb Sum of aldicarb, its sulfoxide and its sulfone, expressed as aldicarb Azinphos-methyl y Azoxystrobin y Bifenthrin y Bromopropylate y Bupirimate n Buprofezin n Captan (b) y Carbaryl y Carbendazim and Sum of benomyl and carbendazim expressed as carbendazim y benomyl Clofentezine y Chlormequat (c) y Chlorothalonil y Chlorpropham Chlorpropham and 3-chloroaniline, expressed as Chlorpropham y Chlorpyrifos y Chlorpyrifos-methyl y Cypermethrin Cypermethrin including other mixtures of constituent isomers (sum of isomers) y Cyprodinil n Deltamethrin (cisdeltamethrin) y Diazinon y Dichlofluanid y Dichlorvos y Dicofol Sum of p, p' and o,p' isomers y Dimethoate and Sum of dimethoate and omethoate, expressed as dimethoate y omethoate Diphenylamine y Dithiocarbamates Including maneb, mancozeb, metiram, propineb, thiram and y ziram (expressed as CS 2 ) (d) Endosulfan Sum of alpha- and beta-isomers and endosulfan-sulphate, expressed as endosulfan y Fenarimol y Fenhexamid y Fenitrothion y Fludioxonil n Flusilazole y Folpet (b) y Hexaconazole y Hexythiazox y Imazalil y Imidacloprid n Indoxacarb Sum of the isomers S and R y Iprodione y Iprovalicarb y Kresoxim-methyl y Lambda-cyhalothrin y Malathion Sum of malathion and malaoxon expressed as malathion y y y 21

22 Pesticide Mepanipyrim Mepiquat (c) Metalaxyl Methamidophos Methidathion Methiocarb Methomyl and thiodicarb Myclobutanil Oxamyl Oxydemeton-methyl Parathion Penconazole Phosalone Pirimicarb Residue definition according to Regulation 396/2005 on EU-MRLs (a) Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)- 6-methylpyrimidine,) expressed as mepanipyrim Metalaxyl including other mixtures of constituent isomers including metalaxyl-m (sum of isomers) Sum of methiocarb and methiocarb sulfoxide and sulfone, expressed as methiocarb Sum of methomyl and thiodicarb expressed as methomyl Sum of oxydemeton-methyl and demeton-s-methylsulfone expressed as oxydemeton-methyl Sum of pirimicarb and desmethyl pirimicarb expressed as pirimicarb EU MRL in place on 01/01/2008? (y/n) n Pirimiphos-methyl y Prochloraz Sum of prochloraz and its metabolites containing the 2,4,6- y trichlorophenol moiety expressed as prochloraz Procymidone y Profenofos y Propargite n Pyrethrins y Pyrimethanil y Pyriproxyfen n Quinoxyfen y Spiroxamine y Tebuconazole n Tebufenozide n Thiabendazole y Thiophanate-methyl y Tolclofos-methyl n Tolylfluanid Sum of tolylfluanid and dimethylaminosulfo-toluidide expressed y as tolylfluanid Triadimefon Sum of triadimefon and triadimenol y Trifloxystrobin y Vinclozolin Sum of vinclozolin and all metabolites containing the 3,5- dichloraniniline moiety, expressed as vinclozolin y (a): If not specifically mentioned the residue definition comprises the parent compound only. (b): MRL was set as sum of captan and folpet until 1 September From that time the MRLs were separate for pome fruit, tomatoes and certain others. (c): Chlormequat and mepiquat should be analysed in carrots, fruiting vegetables (cucumbers) and pears only. (d) In September 2008 the residue definition for dithiocarbamates (maneb group) changed from maneb, mancozeb, metiram, propineb and zineb expressed as CS 2 to Dithiocarbamates (dithiocarbamates expressed as CS 2, including maneb, mancozeb, metiram, propineb, thiram and ziram). y y y y n y y y y y y y n 22

23 Comparing the data submitted by the reporting countries with the Recommendation, it becomes evident that some Member States did not analyse the requested pesticides in all samples. 13 pesticides were analysed in less than 50% of the samples, 30 in less than 60% of the samples. These are mainly substances which can only be analysed with single-residue methods and are considered to be very resource consuming. However, it should be noted that in 2008 participation in the EU coordinated programme was not yet mandatory Number of samples The Monitoring Recommendation (EC 2008a) indicates the minimum number of samples to be analysed in the framework of the 2008 EU coordinated programme, varying from 12 or 15 to 93 samples per product depending on the population of the Member State 10. Table gives an overview of the number of samples requested and the actual number of samples taken by each reporting country for each commodity. A total number of 11,610 samples of nine different commodities were analysed in the 2008 EU coordinated pesticide monitoring programme (Figure ). Denmark; 445 Portugal; 462 Spain; 537 Poland; 409 Finland; 365 Sweden; 380 Norway; 362 Slovenia; 318 Belgium; 292 Ireland; 283 Bulgaria; 278 Cyprus; 262 Czech Republic; 254 Greece; 215 Hungary; 150 Estonia; 121 Lithuania; 114 Slovakia; 112 Austria; 103 Latvia; 100 Luxembourg; 96 Germany; 729 Malta; 77 Iceland; 46 Italy; 1747 Romania; 796 Netherlands; 808 France; 813 United Kingdom; 936 Figure : Number of surveillance samples in 2008 EU coordinated programme taken by reporting 10 The number of samples to be analysed was derived on the basis of a binomial probability distribution, which estimated that the examination of 642 samples allows with a certainty of more than 99 %, the detection of a sample containing pesticide residues above the limit of determination (LOD), provided that not less than 1 % of products of plant origin contain residues above that limit. According to Recommendation 2008/10//EC the collection of these samples should be apportioned between Member States on the basis of population and consumer numbers, with a minimum of 12 samples per product and per year. 23

24 countries. Total number of samples: 11,610 24

25 Table : Number of samples taken by each reporting country for the 2008 EU coordinated programme by commodity. Country Minimum number of Beans Carrots Cucumber Mandarins Oranges Pears Potatoes Rice Spinach samples per commodity without pods ** ** Austria 12/15* Belgium 12/15* Bulgaria 12/15* Cyprus 12/15* Czech Republic 12/15* Denmark 12/15* Estonia 12/15* Finland 12/15* France Germany Greece 12/15* Hungary 12/15* Iceland Not specified Ireland 12/15* Italy Latvia 12/15* Lithuania 12/15* Luxembourg 12/15* Malta 12/15* Netherlands Norway Not specified Poland Portugal 12/15* Romania Slovakia 12/15* Slovenia 12/15* Spain Sweden 12/15* United Kingdom Total *: The minimum of 12 samples has to be taken if a single residue method has to be applied. Otherwise (i.e. multi residue methods) 15 samples are the minimum. **: The minimum number of samples refers to the sum of mandarins and oranges. 25

26 It was noted that for beans without pods, 17 reporting countries did not report the number of samples as specified in the Monitoring Recommendation, probably because this food commodity is not available in these countries. EFSA therefore recommends replacing beans without pods with an alternative food commodity commonly available in all reporting countries and which is relevant regarding the food consumption. As an alternative product green beans with pods are proposed. For the other food commodities most Member States could comply with the Monitoring Recommendations or they even significantly exceeded the number of samples. The 2008 Monitoring Recommendations (EC 2008a) proposed a list of food commodities, a list of pesticides to be analysed in these commodities and the number of samples of these commodities to be analysed by each country. From the actual number of determinations performed in 2008 it can be seen that the expected number of determinations (calculated from the recommended number of substances and the recommended number of samples taken) has not been achieved (Figure ). This could be caused by resource limitation in the reporting countries or by analytical difficulties. However, it should be recalled that participation to the EU coordinated monitoring programme was not yet mandatory in Spinach Rice Potatoes Pears Oranges Mandarins Cucumbers Carrots Beans (without pods) 55% 73% % % 72% % % % % Number of determinations reported Expected number of determinations Figure : Number of actual determinations reported as a percentage of the expected number for each commodity for the 2008 EU coordinated programme National programmes The official controls carried out at national level in the framework of the national monitoring programmes are complementary to the control performed in the context of the EU coordinated programme and are performed to ensure compliance with the provisions established in food legislation regarding pesticide residues. Member States and EFTA countries are free to decide on the design of the national monitoring programmes for pesticide residues in food. In designing their national control plans, the reporting countries typically take into account the following factors: Importance of a commodity in national food consumption; 26

27 Food commodities with high residues/non-compliance rate in previous years; Food consumed fresh or in processed form; Balance of organic/conventional production; Origin of food: domestic, EU or third countries; Sampling at different marketing levels: farm gates, wholesaler, retailer, processing industry, schools or restaurants; Seasonal availability of food commodities; RASFF notifications; Food for sensitive groups of the population, e.g. baby food; Geographic representatives for the reporting country/cultivation area; Food produced by producers with non-compliance in the past; Food commodities not included in the EU coordinated programme. Regarding the pesticides included in the national control programmes, the reporting countries consider: Use pattern of pesticides; Toxicity of the active substances; Cost of the analysis: single methods /multiple methods; Capacity of laboratories. More details on the design of the national monitoring programmes are reported in Appendix II of the current report. The number of samples and the analytical scope of the analysis performed by the participating countries are strongly determined by national budgets. Thus, reporting countries have to focus on specific aspects which are considered most relevant for their national control activities. These results are of value for consumer exposure assessment at national level; however, due to the variability of the programme designs, they should not be used for between-country comparisons at European level or for exposure assessment for the European population Number of samples national programmes The total number of samples taken in the context of the national programmes in 2008 was 70, Compared with the previous year, this is a decrease of 5.9 %. In Figure the distribution of the total samples taken among the reporting countries is displayed. 11 This figure also comprises the number samples taken for the EU coordinated programme since in many countries these samples were analysed for a wider range of active substances than defined in the coordinated programme and therefore belong to both programmes, the national and the EU coordinated programme. 27

28 Netherlands; 4335 United Kingdom; 2327 Greece; 2496 Romania; 3174 Hungary; 3584 France; 5063 Finland; 2083 Denmark; 2048 Austria; 1983 Belgium; 1709 Poland; 1613 Sweden; 1600 Norway; 1493 Slovenia; 1267 Ireland; 1014 Bulgaria; 971 Czech Republic; 919 Slovakia; 894 Portugal; 758 Lithuania; 527 Cyprus; 522 Estonia; 316 Iceland; 277 Luxembourg; 139 Latvia; 110 Malta; 97 Germany; Spain; 6353 Italy; 6788 Figure : Total number of samples taken in 2008 by each reporting country (surveillance and enforcement samples of fruit, vegetables, cereals, processed commodities and baby food). The number of samples taken by the participating countries, normalised by the population is depicted in Figure

29 Figure : Number of samples taken in 2008 by each reporting country (surveillance and enforcement samples of fruit, vegetables, cereals, processed commodities and baby food) normalised by the national population. Depending on the sampling strategy applied, i.e. the degree of targeting in selecting the samples to be analysed for pesticide residues, the national programmes are classified as either surveillance or enforcement programmes. In the surveillance programmes, samples are taken without any particular suspicion towards a specific producer and/or consignment. The EU coordinated programme is an example of surveillance programme. However, the national surveillance programmes are in most cases more targeted to achieve the objectives defined in the national control programmes and are therefore already focussed on specific pre-selected consignments or lots. In 2008, the majority of the samples taken are classified as surveillance samples (67,887 samples, 96.8% of the total number of samples). Table splits them up into the different product groups. Table : Number of surveillance samples (food of animal origin not included). Product Sampling strategy No of samples Babyfood Surveillance 2062 Cereals Surveillance 3931 Processed Surveillance 3110 Fruit and vegetables Surveillance Total surveillance

30 The number of surveillance samples taken and normalised per 100,000 inhabitants varied from 3 (Poland) to 88 (Iceland) (Figure ). Figure : Number of surveillance samples of fruit, vegetables, cereals normalised by the national population (100,000 inhabitants) In enforcement programmes, the probability of finding samples with positive results or samples exceeding the legal limits is higher than in surveillance programmes in which, by definition, the selection of samples is randomised and not directed towards a specific food sample/consignment of a defined population of a given crop (e.g. apples). Thus, the key difference between surveillance and enforcement sampling is not so much targeting but randomisation of the selected samples. Surveillance samples could be targeted for specific food products and countries, but the selection of samples is randomised. In enforcement sampling the samples are not taken randomly and therefore cannot be considered representative of the food item available in the market place. Typically, enforcement samples are collected if there is a suspicion about the safety of a product and/or as follow-up of violations found previously. Follow-up or enforcement sampling is directed to a specificgrower/producer or to a specific food consignment. The reader should be aware that because of this difference the results reported by different countries on the enforcement sampling cannot directly be compared with the results of surveillance sampling. The total number of enforcement samples taken by all reporting countries was 2,256 (3.2% of the total number of samples). In Table , the breakdown of the total enforcement samples according to the food products is reported. 30

31 Table : Number of enforcement samples (food of animal origin not included). Product Sampling strategy No of samples Babyfood Enforcement 7 Cereals Enforcement 116 Processed Enforcement 112 Fruit and vegetables Enforcement 2021 Total enforcement 2256 The distribution of the enforcement samples over the reporting countries can be found in figure Figure : Number of enforcement food samples normalised by the national population (100,000 inhabitants) Pesticides analysed national programmes In 2008, approximately 500 pesticides were authorised for use as plant protection products in EC Member States 12. However, more than 1,000 pesticides can potentially be used as plant protection products worldwide and may result in residues in food traded and consumed in Europe. 12 Information from the European Commission database available at: 31

32 In 2008 the number of pesticides sought 13 by the reporting countries, varied from 39 (Bulgaria) to 679 (Germany) (Figure ). The total number of substances covered by all reporting countries was 862. In 2006 and 2007 the analytical methods used for pesticide monitoring covered 769 and 870 pesticides, respectively. The slight decrease regarding the number of pesticides sought compared with the previous year is due to the introduction of the standard coding system for pesticide names which avoided double counting of identical pesticides if reported with different spelling (e.g. names reported in different languages). The average number of pesticides sought in 2006, 2007 and 2008 were 209, 218 and 235 respectively (Figure ). Figure : The number of pesticides analysed in 2008 by each reporting country (surveillance samples only). It should be noted that the reporting countries did not analyse all the pesticides indicated in the figures in all samples. 13 The number of pesticides sought refers to the residue definitions (see also glossary). Metabolites or degradation products included in a residue definition are not counted separately. 32

33 Number of pesticides Total number of pesticides Average number of pesticides Sampling year Figure : Total and average number per country of different pesticides sought in national and EU pesticide monitoring programmes These figures demonstrate that reporting countries made considerable progress in expanding their analytical capacities, which is an important element in guaranteeing food safety. However, it is also noted that in certain reporting countries there is still a need to further improve the analytical methods to ensure that the pesticides used on food commodities can be analysed and that the competent national authorities are able to enforce the European pesticide residue legislation properly Food commodities analysed national programmes The EU MRL legislation lists about 400 agricultural commodities for which MRLs have been established. The commodities have been classified in ten main food categories. These products and product groups refer to unprocessed raw commodities of plant or animal origin which are placed on the market. The description of the commodities and the parts of the products to which the MRLs apply can be found in the Annexes of the basic MRL directives (EEC 1976; EEC 1990; EEC 1986a and EEC 1986b) and in Annex I to Regulation (EC) No. 396/2005 (EC 2005a). In 2008, approximately 200 different food commodities were analysed for pesticide residues by all reporting countries. The number of different raw commodities sampled by the reporting countries is shown in Figure

34 Figure : The number of different raw commodities sampled in the national and EU programmes by each country (excluding processed and baby food) Baby food monitoring A general default EC MRL of 0.01 mg/kg is applicable for all pesticides, unless specific MRLs lower than 0.01 mg/kg are established under the specific EU legislation (see Background information section) for baby food (Table ). Table lists the pesticides which shall not be used in agricultural production intended for the production of infant and follow-on formulae, processed cerealbased foods and baby foods for infants and young children. They are considered as not used if their residues do not exceed mg/kg. Table : Substances for which specific MRLs lower than 0.01 mg/kg are established for baby food. Chemical name of the substance MRL (mg/kg) Cadusafos Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-s-methyl) Ethoprophos Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) Propineb/propylenethiourea (sum of propineb and propylenethiourea)

35 Table : Substances which shall not be used in agricultural production intended for the production of infant formulae and follow-on formulae use as baby food. Chemical name of the substance (residue definition) Aldrin and dieldrin, expressed as dieldrin Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton) Endrin Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion) Fentin, expressed as triphenyltin cation Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop) Heptachlor and trans-heptachlor epoxide, expressed as heptachlor Hexachlorobenzene Nitrofen Omethoate Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos) In 2008, a total of 2,062 surveillance samples of baby food were reported by 25 countries (Figure ). Three countries did not include any baby food samples in the control programme although the European monitoring recommendations recommended that each Member State should take at least ten samples. Figure : Number of baby food samples (total baby food, i.e. infant formulae, fruit based baby food and cereal based baby food) normalised by the national population (100,000 inhabitants) 35

36 Organic food monitoring At EU level no specific MRLs for organic products have been established, but Council Regulation (EEC) No. 2092/91 on organic production of agricultural products (EC 1991b) defines specific labelling provisions and production methods which entail significant restrictions on the use of pesticides which may have detrimental effects on the environment or result in the presence of residues in agricultural products. The products listed in Table may only be used in cases of immediate threat to the crop, provided that the products are used in accordance with the provisions established at Member State level. Table : Pesticides that can be used in organic farming Group Name Description, compositional requirement, conditions for use I. Substances of crop or animal origin Azadirachtin extracted from Insecticide Azadirachta indica (Neem tree) Beeswax (a) Pruning agent Gelatine Insecticide Hydrolysed proteins (a) Attractant, only in authorized applications in combination with other appropriate products of this list Lecithin Fungicide Plant oils (e.g. mint oil, pine oil, Insecticide, acaricide, fungicide and sprout inhibitor caraway oil). Pyrethrins extracted from Insecticide Chrysanthemum cinerariaefolium Quassia extracted from Quassiaamara Rotenone extracted from Derris spp. and Lonchocarpu sspp. and Terphrosia spp. Insecticide, repellent Insecticide II. Micro-organisms used for biological pest and disease control Micro-organisms (bacteria, viruses and fungi) IIa. Substances produced by micro-organisms Spinosad Insecticide. Only where measures are taken to minimize the risk to key parasitoids and to minimize the risk of development of resistance III. Substances to be used in traps and/or dispensers Diammonium phosphate (a) Attractant, only in traps Pheromones Attractant; sexual behaviour disrupter; only in traps and dispensers Pyrethroids (only deltamethrin or Insecticide; only in traps with specific attractants; only lambdacyhalothrin) against Bactrocera oleae and Ceratitis capitata Wied. IIIa. Preparations to be surface-spread between cultivated plants Ferric phosphate (iron (III) Molluscicide orthophosphate) IV. Other substances from traditional use in organic farming Copper in the form of copper Fungicide. Up to 6 kg copper per ha per year. For perennial hydroxide, copper oxychloride, crops, Member States may, by derogation from the (tribasic) copper sulphate, cuprous previous paragraph, provide that the 6 kg copper limit can oxide,copper octanoate be exceeded in a given year provided that the average quantity actually used over a 5-year period consisting of that year and of the four preceding years does not exceed 6 kg Ethylene (a) Degreening bananas, kiwis and kakis; Degreening of citrus fruit only as part of a strategy for the prevention of fruit fly 36

37 Group Name Description, compositional requirement, conditions for use damage in citrus; Flower induction of pineapple; sprouting inhibition in potatoes and onions Fatty acid potassium salt (soft soap) Insecticide Potassium aluminium (aluminium Prevention of ripening of bananas sulphate) (Kalinite) (a) Lime sulphur (calcium polysulphide) Fungicide, insecticide, acaricide Paraffin oil Insecticide, acaricide Mineral oils Insecticide, fungicide; only in fruit trees, vines, olive trees and tropical crops (e.g. bananas) Quartz sand (a) Repellent Sulphur Fungicide, acaricide, repellent 7. Other substances Calcium hydroxide Fungicide. Only in fruit trees, including nurseries, to control Nectria galligena Potassium bicarbonate Fungicide (a): In some countries the product is not categorized as a plant protection product. The European Commission recommended taking at least one sample originating from organic farming of beans (fresh or frozen, without pod) carrots, cucumbers, oranges or mandarins, pears, potatoes, rice and spinach (i.e. the products covered by the coordinated programme). The percentage of samples of organic farming should reflect the market share of organic produce in each Member State. In 2008, a total of 3,131 samples of organic origin were taken by a total of 22 countries (Table and Figure ). Table : Number of samples of the national and EU coordinated monitoring programmes for pesticide residues in organic food (surveillance and enforcement samples) in 2008 Product Number of samples analysed Baby food 150 Cereals 335 Processed food 167 Fruit and vegetables 2479 Total

38 Figure : Number of organic food samples normalised by the national population (100,000 inhabitants) and reported in the framework of Regulation (EC) No 396/2005. In some of the reporting countries the production type was not recorded in the national data management systems used to handle the sample information 14. Therefore it is assumed that more samples were taken and analysed but could not be reported accordingly Processed-food monitoring For processed or composite food commodities, the MRLs established in the MRL legislation for raw commodities are applicable, taking into account changes in the levels and the nature of pesticide residues caused by processing or mixing (processing factors). Annex VI of Regulation (EC) No 396/2005 (EC 2005a), which will include processing factors for processed products, has not yet been established but other sources provide summary information on the fate of pesticides under processing conditions. These sources can be considered to enforce the legal provisions in processed food (e.g. a German database developed by the Federal Institute for Risk Assessment 15 ). In 2008, a total of 3,110 samples of processed products were taken by 23 countries. This is 5% of the total surveillance samples. The sampling of processed products in the individual reporting countries is outlined in Figure Belgium has taken organic food samples but has reported the results of their analysis in the framework of another EU legislation (i.e. Regulations EC No 834/2007, 889/2008 and 1235/2008) and not in the framework of Regulation 396/ The database is available at (BfR compilation of ). 38

39 Figure : Number of processed food samples normalised by the national population (100,000 inhabitants) Origin of samples National programmes cover samples originating from national, Community and third country production (Figure ). The majority of samples taken were produced in one of the reporting countries (77%). 20% of the samples were taken from imported consignments or lots. In 3% of the samples the origin of the samples was not reported. 39

40 Imported 20% Unknown 3% EU 77% Figure : Origin of samples (EU: EU, Iceland and Norway; Imported: third countries); surveillance and enforcement samples of fruit, vegetables, cereals, processed commodities and baby food. The data submitted by the reporting countries demonstrate that the ratio of samples with EU provenience and samples imported from third countries varied significantly; this ratio is affected by the percentage of imported food consumed in a specific country (e.g. in the Nordic countries). In addition, some countries focus their national monitoring programmes on domestic production. Finally, the level of enforcement sampling can affect this value: in the case of e.g. Lithuania, the majority of imported samples come from enforcement sampling of fruit and vegetables (Figure ). 40

41 Figure : Ratio of samples from EU to samples from third countries from surveillance programmes in reporting countries 2.3. Quality assurance In accordance with Art. 12 of Regulation 882/2004 (EC 2004), laboratories designated for official controls must be accredited to ISO/IEC (ISO 2005), or make use of the derogation in Art. 18 of Regulation 2076/2005 (EC 2005b). Non-accredited laboratories must, as a minimum, have a quality system as described in document SANCO/3131/2007 (EC 2007b) on Method Validation and Quality Control Procedures for Pesticide Residues Analysis in Food and Feed. In 2008, the majority of countries used accredited laboratories for the monitoring programmes, but in seven countries one or more non-accredited laboratory analysed some or all of the samples (Figure 2.3-1). Since the exemption for non-accredited laboratories expired at the end of 2009 (Art. 1 of Regulation (EC) No 2076/2005 (EC 2005b)), it is important that all laboratories contributing to the EU monitoring programmes make efforts to obtain accreditation. 41

42 Bulgaria France Greece Italy Portugal Romania Spain 0% 0% 28% 50% 49% 56% 64% 68% 71% 83% 78% 81% 83% 98% 0% 20% 40% 60% 80% 100% % laboratories accredited % samples analysed accredited Figure 2.3-1: Status in 2008 for those contributing countries where not all samples were analysed by accredited laboratories. 42

43 3. Results of the EU-coordinated monitoring programme 3.1. Overall results for MRL exceedances The analysis of the results of the 2008 EU-coordinated programme shows that 2.2% of the samples exceeded the MRL, while 36% of samples had measurable residues above the reporting level, but below or at the MRL. In 62% of the samples no residues were measured (Figure 3.1-1). No measurable residues 62.1% MRL 35.7% > MRL 2.2% Figure 3.1-1: Overall frequency of samples with and without measurable residues in the 2008 EU coordinated program ( MRL: Samples with measurable residues below or at the MRL; >MRL: Samples with residues above the MRL). Total number of samples: The overall 2008 MRL exceedance rate was comparable with the previous year s rate (2.3%). It is noted that the percentage of samples without measurable residues significantly increased from 52.7% in 2007 to 62.1% in However, it should be noted that in the previous monitoring programme different food commodities were sampled and analysed and the MRL exceedance rate is dependent on the combination of crops analysed in the EU programme. In 2005 and 2008 the same food commodities were analysed under the EU coordinated programmes, but the number of pesticides to be monitored increased from 55 in 2005 to 78 in A comparison of the results obtained in these two years showed an increase regarding the overall percentage of samples without measurable residues (58% in 2005 to 62% in 2008). Considering the wider scope of the monitoring programme and a general improvement in the sensitivity of analytical methods an increase of the rate of samples with measurable residues would be expected. Furthermore, a slight decrease in the overall MRL exceedance rate from 2.8% in 2005 to 2.2% in 2008 was observed. A possible explanation of these positive trends is the implementation of the general provisions of the food law (Regulation (EC) No. 178/2002) which imposes the responsibility on food business operators at all stages of production, processing and distribution to ensure that food satisfies the legal requirements by implementing appropriate control systems. The lower MRL exceedance rate may also partially be ascribed to the new harmonised EU legal limits. However, the impact of the new legal 43

44 limits on the monitoring findings will be best evaluated by assessing future monitoring data, starting from the 2009 monitoring results Results by country The MRL exceedance rate, as reported by each country, is depicted in Figure It is noted that the rates vary greatly among the reporting countries, ranging from 0% to 12% of the samples analysed. The reason for this significant variation could be ascribed not only to the difference in the occurrence of the residues measured in the samples taken by the reporting countries, but also to the difference in the different national MRLs applicable in the reporting countries in 2008, the analytical performances of the national laboratories, and the scope of the analytical methods in the countries (see Figure and Table ). More details on findings on the nine commodities analysed in the 2008 EU coordinated programme are reported in Tables G, H and I of Appendix III. Figure 3.2-1: Rate of MRL-exceeding samples in the 2008 EU coordinated programme by country Results by food commodity Nine food commodities were analysed in the 2008 EU coordinated monitoring programme. The highest percentage of samples exceeding the MRL was identified for spinach (6.2%) followed by oranges (3.0%), rice (2.4%), cucumbers (2.1%), mandarins (2.0%), carrots (1.8%), pears (1.6%), beans without pods (0.8%) and potatoes (0.5%). 44

45 Mandarins had the highest percentage of samples with measured pesticide residues below or at MRLs (78%) followed by 66% of the orange samples and 57% of the pears. Samples of cucumbers, potatoes, spinach, rice, carrots and beans without pods contained measurable residues at or below the MRL less frequently (Figure 3.3-1). Furthermore, the proportion of samples with measurable residues is higher in fruit crops (67.9%) than vegetables (21.2%). The same was observed with the commodity sampled in the framework of the 2007 EU coordinated programme where other food commodities were tested. Spinach 78.5% 15.3% 6.2% Oranges 30.8% 66.2% 3.0% Rice 83.7% 13.9% 2.4% Cucumbers 69.2% 28.7% 2.1% Mandarins Carrots 20.2% 84.5% 77.8% 13.7% 2.0% 1.8% Pears 40.8% 57.6% 1.6% Beans (without pods) 91.1% 8.1% 0.8% Potatoes 78.5% 21.0% 0.5% 0% 20% 40% 60% 80% 100% No measurable residues Measurable residues below or at the MRL Residues above the MRL Figure 3.3-1: Percentage of samples with no measurable residues, with measurable residues below or at the MRL and with residues above the MRL (national or EC MRL) for the nine food commodities analysed in the 2008 EU coordinated monitoring programme. Total number of samples: 11,610. Compared with the results of the 2005 EU coordinated monitoring, where the same food commodities were analysed, a general trend is observed towards a higher percentage of samples without detectable residues. 45

46 Spinach Oranges Rice Cucumbers Mandarins Carrots Pears Beans (without pods) Potatoes 20% 18% 31% 27% 29% 41% 79% 78% 84% 80% 69% 69% 85% 79% 64% 79% 73% 91% 0% 20% 40% 60% 80% 100% Figure 3.3-2: Percentage of samples with no measurable residues for the nine food commodities analysed in the 2005 and 2008 EU coordinated monitoring programmes. The increased percentage of samples free of measurable residues is surprising since the scope of the coordinated programme has been extended and analytical methods have been improved with regard to their sensitivity. Having more active substances in the programme would increase the probability of positive findings. More sensitive methods allow detection of even lower concentrations of pesticide residues in samples which would not be detectable with less sophisticated analytical methods. The percentage of samples exceeding the MRLs has increased for some commodities (rice, carrots, cucumbers and pears), whereas for spinach, potatoes, oranges and mandarins the percentage of samples exceeding the MRLs has decreased. For beans a direct comparison is not possible since in 2005 also French beans were sampled. In Figure the comparison of the MRL exceedance observed in 2005 and 2008 is depicted. The increased number of MRL exceedances for rice, carrots, cucumbers and pears seems to be alarming. However, many MRLs have changed between 2005 and 2008 (e.g. significant changes have been introduced with the harmonisation of MRLs in September 2008). Therefore the MRL exceedance rate is a relative parameter depending on the level of the MRLs established during the reference period. A detailed analysis of the development of the individual 495 MRLs for the 55 pesticide/crop combinations for which data from 2005 and corresponding data in 2008 are available would be required to conclude if the situation has deteriorated since However, since the individual residue concentrations measured in 2005 are not available, this analysis is not possible. EFSA is of the opinion that, instead of the MRL exceedance rates, the results of the exposure assessments are a better indicator by which to observe trends in human exposure to pesticide residues (see section 5). 46

47 Spinach Oranges Rice Cucumbers Mandarins Carrots Pears Beans (without pods) Potatoes 3.0% 1.2% 2.4% 1.2% 2.1% 1.9% 2.0% 2.7% 1.8% 1.4% 1.6% 0.8% 0.8% 0.5% 1.2% 6.2% 6.6% 8.4% 0.0% 2.0% 4.0% 6.0% 8.0% 10.0% Figure 3.3-3: Percentage of samples with residues above the MRL for the nine food commodities analysed in the 2005 and 2008 EU coordinated monitoring programmes Results by pesticide-commodity combination In this section (Figures to 3.4-9) more detailed findings for the nine commodities covered by the coordinated programme are reported. The charts present the percentage of samples containing residues of the 78 pesticides included in the programme: the orange bars relate to the upper scale (0 1%) and show the percentage of samples with residues above the MRL. The blue bars relate to the lower scale (0 10%) and show the percentage of samples with measurable residues above the reporting limit, but below the MRL. For each commodity, the pesticides found in that commodity are sorted according to the frequency of samples with residue findings above the reporting limit (including samples with residues above the quantification level and above the MRL). It should be noted that not all samples have been analysed for all active substances. For this reason, the same number of samples with detection or instances of exceedance can result in different frequencies within the same commodity. 47

48 Beans (without pods) % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% Azoxystrobin Cyprodinil Pyrethrins Dichlofluanid Dithiocarbamates Endosulfan (sum) Thiabendazole Cypermethrin (sum) Procymidone Triadimefon (sum) Pyrimethanil Lambda Cyhalothrin Captan/Folpet (sum) Iprodione Chlorpyrifos Malathion (sum) 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-1: Percentage of samples of beans (without pods) above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 381. In beans without pods, 16 different pesticides were found in measurable amounts in the 381 samples. The most frequent active substances found were azoxystrobin, cyprodinil and pyrethrins. Only procymidone (two samples) and iprodione (one sample) were found to exceed the MRL; the MRLs for both substances are at the LOQ, so no residues for these pesticides were found below the MRL. 48

49 Carrots % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% Tebuconazole Iprodione Azoxystrobin Chlorpyrifos Tolclofos methyl Dithiocarbamates Pyrimethanil Pyrethrins Dimethoate (sum) Chlorothalonil Metalaxyl (sum) Procymidone Chlorpyrifos methyl Vinclozolin (sum) Endosulfan (sum) Malathion (sum) Methiocarb (sum) Diazinon Captan Myclobutanil Triadimefon (sum) Iprovalicarb Oxamyl Methomyl (sum) Trifloxystrobin Thiabendazole Folpet Fludioxonil Buprofezin Imazalil Methamidophos Cyprodinil Kresoxim methyl Chlorpropham (sum) 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-2: Percentage of samples of carrots above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 1,530. In total, 34 different pesticides were found in 1,530 samples of carrots. The most frequently found active substances were tebuconazole, iprodione and azoxystrobin. MRL exceedances were observed for eight active substances. Chlorpyrifos (0.7%, 10 samples) and iprodione (0.6%, 8 samples) showed the highest rate of exceedance. Exceedances were also found for dimethoate, procymidone, chlorpyriphos-methyl, endosulfan, diazinon and folpet (1 3 samples each). 49

50 Cucumbers % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% Azoxystrobin Chlorothalonil Dithiocarbamates Procymidone Metalaxyl (sum) Cyprodinil Iprodione Imidacloprid Carbendazim and benomyl Pyrimethanil Triadimefon (sum) Fludioxonil Cypermethrin (sum) Methomyl (sum) Endosulfan (sum) Bupirimate Imazalil Methiocarb (sum) Chlormequat Oxamyl Myclobutanil Fenhexamid Acetamiprid Indoxacarb Kresoxim methyl Thiophanate methyl Bifenthrin Chlorpyrifos Vinclozolin (sum) Thiabendazole Pirimicarb (sum) Penconazole Dimethoate (sum) Spiroxamine Trifloxystrobin Buprofezin Pyrethrins Methamidophos Tolylfluanid Tebufenozide Chlorpyrifos methyl Clofentezine Hexythiazox Mepanipyrim Hexaconazole Captan Lambda Cyhalothrin Malathion (sum) Bromopropylate Pirimiphos methyl 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-3: Percentage of samples of cucumbers above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 1,329. In total, 50 different pesticides were found in 1,329 cucumber samples. The most frequent found active substances were azoxystrobin, chlorothalonil and dithiocarbamates. MRL exceedances were observed for 14 active substances. The highest rate of exceedance was found for carbendazim/benomyl and methomyl (0.6%, 5 samples each). 50

51 Mandarins % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% Imazalil 72% Chlorpyrifos 47% Thiabendazole 35% Malathion (sum) 21% Pyriproxyfen 12% Prochloraz Dithiocarbamates Dicofol Carbendazim and benomyl Hexythiazox Methidathion Imidacloprid Chlorpyrifos methyl Bromopropylate Myclobutanil Lambda Cyhalothrin Buprofezin Pyrimethanil Propargite Pirimiphos methyl Carbaryl Cypermethrin (sum) Endosulfan (sum) Azoxystrobin Phosalone Fenitrothion Metalaxyl (sum) Dimethoate (sum) Clofentezine Diphenylamine Vinclozolin (sum) Tebuconazole Azinphos methyl Iprodione Acetamiprid Thiophanate methyl Profenofos Cyprodinil Chlorpropham (sum) Bifenthrin Parathion Deltamethrin Diazinon Procymidone 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-4: Percentage of samples of mandarins above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 1,032. In mandarins (1,032 samples) 44 different pesticides were detected some of these in quite high frequencies: Imazalil, chlorpyriphos, thiabendazole, malathion and pyriproxyfen were all found in more than 10% of the samples; imazalil in 72%. Eight different pesticides were found in concentrations exceeding the MRL. Imazalil was also found to exceed the MRL in eight samples (0.9%) and carbaryl exceeded the MRL in five samples (0.6%). 51

52 Imazalil Thiabendazole Chlorpyrifos Malathion (sum) Imidacloprid Prochloraz Methidathion Pyriproxyfen Bromopropylate Dithiocarbamates Dicofol Lambda Cyhalothrin Carbendazim and benomyl Pirimiphos methyl Propargite Chlorpyrifos methyl Trifloxystrobin Diazinon Dimethoate (sum) Azoxystrobin Myclobutanil Cypermethrin (sum) Pyrimethanil Profenofos Carbaryl Buprofezin Deltamethrin Metalaxyl (sum) Fenitrothion Acetamiprid Hexythiazox Phosalone Thiophanate methyl Captan Fludioxonil Iprodione Endosulfan (sum) Methomyl (sum) Hexaconazole Folpet Fenhexamid Diphenylamine Pirimicarb (sum) Bifenthrin Dichlofluanid Chlorpropham (sum) Oranges % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% 70% 40% 29% 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-5: Percentage of samples of oranges above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 1,550. In oranges, 46 different pesticides were detected in 1,550 samples analysed - three of these (imazalil, thiabendazole and chlorpyrifos) in more than 10% of the samples. Imazalil was found in 70% of the oranges. 14 different pesticides were found in concentrations exceeding the MRLs. The highest rates of exceedance ( %) were found for diazinon and dimethoate. 52

53 Dithiocarbamates Chlorpyrifos Carbendazim and benomyl Captan/Folpet (sum) Chlormequat Diphenylamine Thiabendazole Azinphos methyl Imazalil Iprodione Thiophanate methyl Imidacloprid Cyprodinil Indoxacarb Trifloxystrobin Fludioxonil Acetamiprid Tebuconazole Lambda Cyhalothrin Chlorpyrifos methyl Cypermethrin (sum) Malathion (sum) Pyrimethanil Kresoxim methyl Bifenthrin Methomyl (sum) Procymidone Tebufenozide Chlorothalonil Phosalone Hexythiazox Buprofezin Deltamethrin Bromopropylate Pirimicarb (sum) Pyrethrins Dichlofluanid Dimethoate (sum) Diazinon Carbaryl Propargite Endosulfan (sum) Methidathion Chlorpropham (sum) Triadimefon (sum) Tolylfluanid Acephate Myclobutanil Fenitrothion Iprovalicarb Clofentezine Fenarimol Dicofol Penconazole Metalaxyl (sum) Pears % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-6: Percentage of samples of pears above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 1, % 17% 15% 14% 13% 13% In pears, 55 different pesticides have been detected. The most frequent pesticides were dithiocarbamates, chlorpyrifos and carbendazim (including benomyl). 13 different pesticides were found in concentrations exceeding the MRLs. Chlormequat was found to exceed the MRL in four samples (0.9%). Five samples (0.3%) exceeded the MRL for diazinon. 53

54 Potatoes % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% Chlorpropham 21% Dithiocarbamates Metalaxyl (sum) Imidacloprid Azoxystrobin Chlorpyrifos Imazalil Thiabendazole Diphenylamine Malathion (sum) Oxamyl Carbaryl Endosulfan (sum) Methomyl (sum) Methiocarb (sum) Methamidophos Vinclozolin (sum) Tebuconazole Dichlofluanid Deltamethrin Dimethoate (sum) Fenitrothion Pirimiphos methyl 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-7: Percentage of samples of potatoes above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 2,054. In potatoes, 23 different pesticides were found (2,054 samples). The most frequent pesticides found were chlorpropham (in 21% of the samples), dithiocarbamates and metalaxyl. MRL exceedances were observed for seven active substances. 54

55 Rice % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% Pirimiphos methyl Carbendazim and benomyl 2.2% Tebufenozide 1.5% Deltamethrin Tebuconazole Imidacloprid Azoxystrobin Malathion (sum) Chlorpyrifos Hexaconazole Acetamiprid Iprodione Prochloraz Chlorpyrifos methyl Dithiocarbamates Cypermethrin (sum) Bupirimate Buprofezin Cyprodinil Triadimefon (sum) Metalaxyl (sum) Dichlorvos Fenitrothion 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-8: Percentage of samples of rice above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 1,060. In 1,060 rice samples, 23 different pesticides were observed. The most frequently found pesticides were pirimiphos-methyl, tebufenozide and carbendazim (including benomyl). Seven pesticides were found in concentrations exceeding the MRLs. Two of these pesticides (carbendazim/benomyl and tebufenozide) were found to exceed the MRL in 2.2% (12 samples) and 1.5% (5 samples) respectively of the samples. 55

56 Spinach % samples with residues above MRL 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% Dithiocarbamates 4.9% Lambda Cyhalothrin Cypermethrin (sum) Deltamethrin Imidacloprid Indoxacarb Chlorpyrifos Azoxystrobin Methomyl (sum) 1.1% Carbendazim and benomyl Bifenthrin Iprodione Pirimicarb (sum) Endosulfan (sum) Fludioxonil Thiabendazole Captan Dimethoate (sum) Pyrethrins Chlorpropham (sum) Cyprodinil Metalaxyl (sum) Tolclofos methyl Chlorpyrifos methyl Procymidone Propargite Methamidophos Dichlofluanid Imazalil Pyrimethanil Chlorothalonil Dicofol Malathion (sum) 0% 2% 4% 6% 8% 10% % samples with measurable residues below or at the MRL Figure 3.4-9: Percentage of samples of spinach above the MRL (upper scale) or with measurable residues below or at the MRL (lower scale) by pesticide for the 2008 EU coordinated programme. Total number of samples: 1,005. In spinach, 33 different pesticides were detected in 1,005 samples. The most frequent pesticides found were the dithiocarbamates, followed by lambda-cyhalothrin, cypermethrin and deltamethrin. 22 pesticides were found in concentrations exceeding the MRL. Dithiocarbamates showed the highest rate of MRL exceedance (4.9%, 25 samples). Also chlorpyrifos, azoxystrobin and methomyl were found to exceed the MRL in more than 0.5% of the samples ( %, 5 7 samples). 56

57 The main pesticide/crop combination where findings above the reporting level were found most frequently, was imazalil/mandarins and oranges (73% and 70%, respectively), chlorpyrifos/mandarins and oranges (29 and 47%, respectively), dithiocarbamates/pears (39%), thiabendazole/mandarins and oranges (35-40%) and captan/pears (36%) (Table 3.4-1). There were four pesticide/crop combinations with MRL exceedances above 1%. The highest percentages were found for dithiocarbamates (as carbon disulfide, CS 2 ) in spinach, where the MRL was exceeded in 4.9% of all samples. In spinach methomyl also exceeded the MRL in 1.1% of all samples. In rice the MRL for carbendazim and tebufenozide was exceeded in 2.2% and 1.5% of all samples. In spinach, five pesticides exceeded the MRL in more than 0.5 % of the samples (Table 3.4-2). 57

58 Table 3.4-1: Most frequent detections of particular pesticide/commodity combinations in the 2008 EU coordinated monitoring programme (results over 10%). Commodity Pesticide and % samples with detectable residues (none) Background information on the active substances found Beans without pods Carrots (none) Cucumber (none) Mandarins imazalil (73%), Systemic fungicide used to control a wide range of fungal or storage diseases in fruit and other crops. chlorpyrifos (47%), thiabendazole (35%), malathion (21%), pyriproxyfen (12%), Non-systemic insecticide used to control different pests in soil or on foliage in fruit and other crops. Systemic fungicide used mainly as post-harvest treatment for the control of a wide range of different fungi species. Non-systemic insecticide and acaricide used on a wide rang of crops to protect against different pests. Insect growth regulator used to control infestation with insect pests. Oranges imazalil (70%), See mandarins thiabendazole (40%), See mandarins chlorpyrifos (29%), See mandarins Pears dithiocarbamates (39%), Group of active substances used to control fungal diseases in a wide range of fruits and other crops. chlorpyrifos (17%), See mandarins captan/folpet (14%), Fungicide used to control a wide range of fungal diseases on pome fruit and other crops. chlormequat (14%), Plant growth regulator used in the past on pear trees to prevent premature fruit drop and fruit thinning. Since 1 December 2009 only the use as plant growth regulator in cereals and in nonedible crops may be authorised. diphenylamine (13%), Post-harvest fungicide protectant and scald inhibitor for pome fruit. Potatoes chlorpropham (21%) Used as post-harvest treatment to avoid sprouting of potatoes. Rice (none) Spinach (none) 58

59 Table 3.4-2: Most frequent MRL exceedances of pesticide/commodity combinations in the 2008 EU coordinated monitoring programme (results over 0.5% only). Commodity Pesticide and % MRL exceedances Beans without pods Procymidone (0.6%) Carrots Iprodione (0.6%), chlorpyrifos (0.7%) Cucumber Carbendazim /benomyl (0.6%), methomyl (0.6%) Mandarins Imazalil (0.9%), carbaryl (0.6%) Oranges Dimethoate (1.0%), diazinon (0.9%) Pears Chlormequat (0.9%) Potatoes (none) Rice Carbendazim/benomyl (2.2%), tebufenozide (1.5%), acetamiprid (0.7%), Spinach dithiocarbamates (5%), methomyl (1.1%), chlorpyrifos (0.8%), azoxystrobin (0.6%), iprodione (0.5%) 3.5. Results by pesticides In the EU coordinated programme residues exceeding the MRL were found for 47 different pesticides (Figure 3.5-1). Residues of dithiocarbamates were found most often exceeding the MRL (0.6% of samples); all of these samples were spinach (see also Table 3.4-2) originating from EU countries (see Table ). Therefore, EFSA recommends the reporting countries to investigate the reason explaining these findings on spinach. Chlormequat (which was only analysed in carrots, cucumber and pears) exceeded the MRL in 0.4% of these samples, all in pears. Carbendazim/benomyl residues above MRL were found in cucumbers, pears, rice and spinach (in total 0.3% of all samples). Exceedance of the MRL for chlorpyrifos, dimethoate, methomyl, diazinon, iprodione, imazalil and endosulfan was found in % of samples (distributed among several commodities), while tebufenozide only exceeded the MRL in rice (0.1% of samples). Carbaryl exceeded the MRL in mandarins, oranges, pears and potatoes (0.1% total). The rates of exceedance for the remaining pesticides were all below 0.1%. Measurable residues were found for 69 different pesticides out of 78 pesticides included in the coordinated programme; 47 of them are shown in Figure The remaining pesticides were each found in less than 0.2% of the samples. No positive detections were found for folpet, acephate, parathion, dichlorvos, aldicarb (sum), flusilazole, mepiquat, oxydemeton-methyl(sum) and quinoxyfen. Chlorpropham (only reported for potatoes 16 ) was found most frequently (21%). Imazalil had measurable residues in 18.3% of the samples; most (17%) were from mandarins and oranges. Chlorpyrifos, captan/folpet, thiabendazole and dithiocarbamates were each found in between 10-12% of the samples; chlorpyrifos (8.6%) and thiabendazole (9.3%) mainly in mandarins and oranges, while captan/folpet 17 (12%) and dithiocarbamates (7.6%) were mainly found in pears. Residues of chlormequat (only analysed for in carrots, cucumber and pears) were found in 6.4% of these samples, most of which (6.2%) were in pears. Malathion, carbendazim/benomyl, imidacloprid, pyriproxyfen and diphenylamine were each found in 4 2 % of samples. Furthermore, 13 pesticides were found in 2 1% of the samples. 22 pesticides were found in 1 0.2% of the samples. 16 In other commodities, residues of chlorpropham were reported as a sum of chlorpropham and 3-chloroaniline, expressed as chlorpropham according to the residue definition). 17 Captan and folpet was reported as a sum for beans (without pod) and pears only. For the remaining commodities in the EU programme, residues of captan and folpet were reported individually. 59

60 Dithiocarbamates Chlormequat Carbendazim and benomyl Chlorpyrifos Dimethoate (sum) Methomyl (sum) Diazinon Iprodione Imazalil Endosulfan (sum) Tebufenozide Carbaryl Oxamyl Chlorpropham Fenitrothion Procymidone Azoxystrobin Acetamiprid Thiabendazole Chlorpyrifos methyl Captan Thiophanate methyl Azinphos methyl Imidacloprid Bifenthrin Cypermethrin (sum) Methiocarb (sum) Folpet Acephate Fludioxonil Profenofos Methamidophos Cyprodinil Pyrimethanil Dicofol Metalaxyl (sum) Clofentezine Pyriproxyfen Chlorpropham (sum) Buprofezin Vinclozolin (sum) Diphenylamine Pirimicarb (sum) Lambda Cyhalothrin Chlorothalonil Parathion Dichlorvos 0.0% 0.1% 0.2% 0.3% 0.4% 0.5% 0.6% Beans (without pods) Carrots Cucumbers Mandarins Oranges Pears Potatoes Rice Spinach Figure 3.5-1: Frequency of samples with measured residues above the MRL in the 2008 EU coordinated monitoring programme. Contributions from each commodity are indicated. 60

61 Chlorpropham Imazalil Chlorpyrifos Captan/Folpet (sum) Thiabendazole Dithiocarbamates Chlormequat Malathion (sum) Carbendazim and benomyl Imidacloprid Pyriproxyfen Diphenylamine Prochloraz Iprodione Azoxystrobin Lambda Cyhalothrin Tebuconazole Methidathion Cyprodinil Cypermethrin (sum) Azinphos methyl Bromopropylate Dicofol Pirimiphos methyl Chlorothalonil Thiophanate methyl Indoxacarb Chlorpyrifos methyl Pyrimethanil Metalaxyl (sum) Fludioxonil Trifloxystrobin Procymidone Acetamiprid Deltamethrin Hexythiazox Myclobutanil Tebufenozide Propargite Buprofezin Methomyl (sum) Bifenthrin Kresoxim methyl Triadimefon (sum) Endosulfan (sum) Phosalone Pyrethrins 0% 5% 10% 15% 20% Beans (without pods) Carrots Cucumbers Mandarins Oranges Pears Potatoes Rice Spinach Figure 3.5-2: Frequency of samples with measurable residues below or at MRL (above 0.20 %) in the 2008 EU coordinated monitoring programme. Contributions from each commodity are indicated. Additional information on the results reported in Figure and Figure can be found in Appendix III (Tables H and I). 61

62 4. Results of the national monitoring programmes Due to the limitations of the format used to report the 2008 monitoring results, it was not always possible to identify the samples taken in the framework of the national programmes or in the framework of the EU coordinated programme. As a consequence, some of the findings reported in this section (e.g. results on the multiple residues) refer to results of both the national and the EU coordinated control activities Overall results for MRL exceedances 96.5% of the surveillance samples analysed (national and EU coordinated programme) were below or at the legal Maximum Residue Levels (MRLs); in 3.5% of the samples the legal limits were exceeded for one or more pesticide. It should be noted that for many of the pesticides detected, EU harmonised MRLs had not yet been established in the first part of Thus, an MRL exceedance in one reporting country did not necessarily represent an exceedance in all others MRL exceedance rate over the time The overall reported MRL exceedance rate (3.5%) is slightly lower than in the previous year where 4.2% of the samples were found to exceed the MRL. Over the last years, the exceedance rate ranged between 3.0 and 5.5%. Figure shows the trend of exceeding/non-exceeding samples from the monitoring reports for 1996 to The figure includes surveillance samples from both the national and the EU coordinated programme. For the period the figure also includes enforcement samples. 62

63 % 96.0% 95.0% 95.0% 95.0% 94.5% 94.5% 96.1% 95.5% 95.7% 96.7% 96.6% 97.0% 3.5% 4.0% 5.0% 5.0% 5.0% 5.5% 5.5% 3.9% 4.5% 4.3% 3.3% 3.4% 3.0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% No measurable residues detected above MRL Residues detected above MRL Figure 4.2-1: MRL compliance rate for samples from the national and EU coordinated pesticide residue programmes Note that for 2008 only surveillance samples are included, while for , enforcement samples are included as well. Although different factors may influence the observation of MRL exceedances, and this hampers a direct comparison, the percentage with residues of samples above the MRL seems to be slightly declining. This is a surprising result since the trend to increase the scope of the analytical methods and the increased sensitivity of analytical methods would be expected to have an effect in the opposite direction, i.e. increased detection of MRL exceedances. The average number of pesticides analysed has increased from 66 in 1999 to 235 in 2008 and the levels of reporting (LOQs) are constantly moving towards lower levels. On the other hand, the results from include enforcement samples (the percentage of enforcement samples and level of targeting is not reported in the previous reports) for which the rate of exceedance is expected to be higher than for surveillance samples Origin of samples exceeding the EC MRLs The participating countries also reported the origin of samples in cases where an MRL exceedance was observed. For 2008, the harmonized EC MRLs were exceeded more often for surveillance samples of fruit, vegetables and cereals imported from third countries (7.6%) than from the EU (2.4%) (Table and Figure 4.3-1). 63

64 Table 4.3-1: Exceedances of EC MRLs according to origin of sample (surveillance samples of fruit, vegetables and cereals). Sample origin Number of samples Samples with EC MRL exceedances LCI a UCI b Number % EU c Imported Unknown Total (a): Lower Confidence Limit (see Background information section) (b): Upper Confidence limit (c): Including EEA countries Table lists the countries from which the highest number of EC MRL exceeding samples were reported, including also details on the imported food products for which MRL exceedances were observed most frequently. The results are also presented in a map (Figure 4.3-1). It is noted that in this presentation the results of the 29 reporting countries are not included (see also Figure 3.2-1). Table 4.3-2: Imported food products most frequently exceeding the MRLs and countries of origin Origin country Number of EC MRL Food products most frequently exceeding EC MRL exceedances Thailand 206 Peppers, Beans (with pods), Basil Turkey 92 Peppers, Table grapes, Pears Colombia 56 Passion fruit, Physalis (Cape gooseberry), Sage Egypt 55 Oranges, Strawberries, Pomegranate India 52 Okra (lady s fingers), Peppers, Pomegranate Brazil 43 Mangoes, Figs, Apples, Limes Dominican Republic 43 Beans (with pods), Aubergines (egg plants), Cucurbits Israel 41 Carrots, Herbs, Strawberries Kenya 35 Beans (with pods), Passion fruit, Peas (with pods) Morocco 34 Peppers, Beans (with pods), Tomatoes China 29 Tea, Grapefruit, Beans (with pods) Chile 20 Peaches, Table grapes, Apples United States 20 Grapefruit, Apples Argentina 18 Lemons, Apples, Pears Costa Rica 16 Pineapples, Passion fruit, Mangoes Vietnam 15 Tea, Lychee (Litchi), Celery, Herbs South Africa 14 Oranges, Lemons, Passion fruit, Pineapples Zimbabwe 14 Passion fruit, Peas (with pods), Peppers Suriname 13 Peppers, Aubergines (egg plants), Celery leaves Jordan 12 Peppers, Okra (lady s fingers), Cucumbers 64

65 Figure 4.3-1: Origin of samples imported from third countries exceeding EC MRLs. Samples include all surveillance samples from the 2008 national and EU pesticide monitoring programmes. 65

66 4.4. Results by food commodity Figure describes the MRL exceedances rate according to the four food categories fruit and vegetables, cereals, processed products and baby food. Most exceedances were found in fruit and vegetables (3.7%) followed by cereals, with 1.5% of samples exceeding the MRL. In processed commodities the MRL was exceeded in 0.9% of the samples, while residues exceeding the MRL were found in 0.2% of the samples of baby food. Figure reports the MRL exceedance rates for some fruit and vegetables sub-groups. Fruit and vegetables Cereals Processed Babyfood 96.3% 98.5% 99.1% 99.8% 3.7% 1.5% 0.9% 0.2% 0% 20% 40% 60% 80% 100% No measurable residues detected above MRL Residues detected above MRL Figure 4.4-1: MRL compliance rate for surveillance samples in the national programme and the EU coordinated pesticide monitoring programme For fruit and vegetables, the MRL exceedance rate was significantly higher for enforcement samples (11.2%) than for surveillance samples (3.7%) (Table and Table 4.4-2). For the other categories no significant difference can be concluded mainly due to the low number of enforcement samples numbers (overlapping confidence interval). In total, 231 samples, corresponding to 10.2 % of all samples, exceeded the MRL. No exceedance of the MRL was seen for the baby food samples, while 2 samples of both the processed and cereals samples exceeded the MRL. In total, residues of 365 different pesticides were found in measurable quantities in fruit and vegetables, while in cereals residues of 76 different pesticides were observed. As in previous years, the number of different pesticide residues found in fruit and vegetables in 2008 was higher than the number of pesticides found in cereals, which also reflects the greater number of products used in the fruit and vegetables category. 66

67 Table 4.4-1: Summary of the results of the national and EU coordinated monitoring programmes (surveillance samples). Product Number of samples analysed Samples with residues below or at the MRL LCI (a) UCI (b) Samples with residues above the MRL Number % Number % Fruit and vegetables Cereals Processed products Baby food Total (a): Lower Confidence Limit (b): Upper Confidence limit LCI (a) UCI (b) Table 4.4-2: Summary of the results of the national and EU coordinated monitoring programmes (enforcement samples). Product Number of samples analysed Samples with residues below or at the MRL LCI (a) UCI (b) Samples with residues above the MRL Number % Number % Fruit and vegetables Cereals Processed products Baby food Total (a): Lower Confidence Limit (b): Upper Confidence Limit In Figure a more detailed presentation of the food commodities or commodity groups 18 is presented, illustrating the MRL exceedance rates observed in the national and EU and coordinated monitoring programmes. The highest percentage of MRL exceedances was identified for herbs, crops belonging to the group miscellaneous fruits with inedible peel, small (e.g. kiwi, lychee and passion fruit), tea and miscellaneous fruit with edible peel (e.g. dates, figs, kumquats). LCI (a) UCI (b) 18 The individual commodities belonging to the groups reported can be found in Annex I of Regulation (EC) No 396/

68 Herbs Misc. fruits with inedible peel, small Tea Leafy brassica Miscellaneous fruits with edible peel Spinach and similar (leaves) Legume vegetables, fresh Misc. fruits with inedible peel, large Pulses, dry Small fruit and berries Tropical root and tuber vegetables Cane fruit Table and Wine grapes Strawberries Solanacea Stone fruit Lettuce and other salad plants Stem vegetables, fresh Citrus fruit Pome fruit Root and tuber vegetables Cucurbits, edible peel Fungi Tree nuts, shelled or unshelled Cucurbits, inedible peel Oilseeds Bulb vegetables Sweet corn Flowering brassica Cereals Oilfruits Potatoes Head brassica Witloof Kohlrabi 84% 91% 91% 92% 93% 93% 94% 95% 95% 95% 95% 96% 96% 96% 96% 97% 97% 97% 97% 97% 97% 97% 97% 97% 97% 98% 98% 98% 98% 98% 99% 99% 99% 99% 100% 16% 9% 9% 8% 7% 7% 6% 5% 5% 5% 5% 4% 4% 4% 4% 3% 3% 3% 3% 3% 3% 3% 3% 3% 3% 2% 2% 2% 2% 2% 1% 1% 1% 1% 0% 0% 20% 40% 60% 80% 100% No measurable residues detected above MRL Residues detected above MRL Figure 4.4-2: Percentage compliance with EC MRL for raw commodities (surveillance samples from EU and national programmes commodity groups with sample size below 50 excluded) 68

69 4.5. Results by pesticide/crop combinations The 33 pesticide/crop combinations with the highest absolute number of MRL exceedances are shown in Figure It should be noted however that the number of positive detections is biased by the commodity sampling frequency (e.g. the crops included in the 3-year cycle of the EU programme are the most frequent samples), the sampling strategies and by the number of reporting countries testing for the specific crop/pesticide combination. The chart also illustrates the percentage of these samples originating from third countries. It is noted that peppers and passion fruit are the commodities which are most frequently reported in Figure The pesticide/crop combinations with the highest percentage of MRL exceedances could not be calculated since the reporting countries only submitted the results of residues above the quantification level. The number of analysed samples of a certain food item which did not contain measurable residue concentrations was not reported to EFSA. 69

70 Dimethoate (sum) Dithiocarbamates Carbendazim and benomyl Boscalid Dimethoate (sum) Diazinon Dimethoate (sum) Folpet Amitraz (sum) Carbendazim and benomyl Carbofuran (sum) Imazalil Dimethoate (sum) Methomyl (sum) Methomyl (sum) Phosalone Phosmet Carbendazim and benomyl Chlorpyrifos Chlorpyrifos Cypermethrin (sum) Imazalil Pendimethalin Spinosad Carbaryl Chlorpyrifos Diazinon Dicofol Difenoconazole Dimethoate (sum) Dithiocarbamates Oxamyl Trifloxystrobin Spinach Peppers Strawberries Oranges Oranges Peppers Table grapes Pears Passion fruit Peppers Lemons Apples Beans (with pods) Peppers Apples Peaches Rice Beans (with pods) Carrots Passion fruit Mandarins Kale Strawberries Apples Peppers Peppers Cherries Passion fruit Passion fruit Pineapples Peppers Passion fruit Beans (with pods) Samples from third countries Figure 4.5-1: Pesticide/crop combinations exceeding the EC MRLs (national and EU pesticide monitoring coordinated programmes 2008 (surveillance samples only)). Proportion of samples originating from third countries is shown besides the total number of samples Results for organic samples Total number of exceedences Data on organic food were only provided by some reporting countries. Due to deficiencies in the data management system implemented at national level, many countries were not able to report the results. 70

71 Table : Summary of the results of the national and EU coordinated monitoring programmes for pesticides residues in organic food (surveillance and enforcement samples) in Product Number of samples analysed Samples without detected residues or none above the MRL LCL (a) UCL (b) Samples with residues above the MRL Number % Number % Fruit and vegetables Cereals Processed Babyfood Total (a): Lower Confidence Limit (b): Upper Confidence limit LCL (a) UCL (b) For fruit and vegetables, a lower rate of MRL exceedances (0.9%) in comparison to conventionally grown fruit and vegetables (3.7%) was found (Table and Table ). However, when comparing the rate of exceedances in organic and conventional products it should be also born in mind that the results of the organic samples comprise data for surveillance and enforcement samples whereas the data for conventional products only refers to surveillance samples. Due to the structure of the reported data, no information is available which pesticides were found in organic samples (e.g. the pesticides included in Regulation (EEC) No 2092/91, see Table ). Therefore a further analysis of the reasons explaining the occurrence of residues in organic food and/or MRL exceedances is not possible. In order to gain further knowledge in this area, reporting countries are encouraged to enable the data management systems to differentiate between organic and conventional products. A new data collection system for reporting this information to EFSA is under implementation Results for baby-food samples A general default EC MRL of 0.01 mg/kg is applicable for all active substances unless specific MRLs lower than 0.01 mg/kg were established in Commission Directive 2006/141/EC for infant formulae and follow-on formulae and in Commission Directive 2006/125/EC for processed cereal-based foods and baby foods for infants and young children. In countries reported data on analysis of baby food. Overall 2,062 samples were analysed. Residues above the reporting level were found in 76 samples, while the MRL was exceeded only in 4 samples (0.2%). The four samples exceeding the MRL were samples of baby food based on fruit and vegetables and the measured residue exceeding the legal limits were boscalid (2 samples), thiabendazole (1 sample) and thiacloprid (1 sample). Due to the limitation of the format used for the data reporting, further analysis of the baby food results could not be performed Results for processed products The MRLs applicable for processed commodities are based on the MRLs established for raw agricultural commodities, taking into account changes in levels of pesticide residues caused by processing or mixing. In 2008, 23 countries reported data on analysis of processed products. A total of 3,110 samples were analysed. Residues above the MRL were found in 27 samples (0.9%). It is not reported which processing factors were applied to derive the MRL for processed commodities. 71

72 Results for samples with multiple residues Considering the results of both the national and the EU coordinated programmes in 2008 (including enforcement samples), residues of two or more pesticides were found in 27% of the analysed samples of fruits, vegetables and cereals (Figure ). The highest number of different pesticides in a single sample was 26 in The highest number of pesticides detected in one sample has increased in the period from 1997 with 8 different pesticides to 29 different pesticides in 2006 (Figure ). In 2007 there was a decrease in the number of different pesticides to 22. In 2008 the number of different pesticides was 26 (found by Germany in a sample of table grapes). Multiple residues were reported by 28 countries. In 2008, 344 samples were found to exceed two or more EC MRLs (Table ). The highest number of EC exceedances is 8, measured in peppers. It is noted that in 2007 fewer samples were found to exceed two or more EC MRLs (158). Also in 2007 the highest number of exceedances in the same commodity was eight. 2 residues: 10.9% 3 residues: 6.5% 1 residue: 20.0% No measurable residues: 53.3% 4 residues: 4.1% 5 residues: 2.4% 6 residues: 1.3% 7 residues: 0.6% 8 residues; 0.9% Figure : Number of residues found in individual surveillance samples from the national and EU coordinated pesticide monitoring programmes

73 Number of pesticides Sampling year Figure : Highest reported number of different pesticides in one sample from 1997 to 2008 in fruit, vegetables and cereals. Table : Summary of results for unprocessed samples with multiple EC MRL exceedances. Commodity Number of EC exceedances in one sample Total number of samples with multiple exceedances Peppers Beans (with pods) Passion fruit Basil Celery leaves Strawberries Lettuce Spinach Okra, lady s fingers Peaches 9 9 Lemons 7 7 Tea Carrots 6 6 Aubergines (egg plants) Celery Lychee (Litchi) Yams Pomegranate 5 5 Tomatoes Rocket, Rucola 4 4 Table grapes 4 4 Currants (red, black and white) 4 4 Parsley 4 4 Oranges 4 4 Apples Pears 3 3 Beet leaves (chard) Apricots 3 3 Cucumbers 3 3 Pineapples 3 3 Spring onions

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